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What We Treat:

Below is a list of conditions for which mesenchymal stem cells have shown excellent safety and efficacy, to varying degrees, in clinical trials in humans, and/or pre-clinical studies in animals. Each diagnosis is followed by a list of some of the most important studies published in high quality peer reviewed medical journals describing results of MSC treatment. This list if not exhaustive and treatment is available for other less common conditions.

Following each study is a short synopsis, including a non-technical summary, of the main point(s) of the study. At the end of the article list is a link to our study on clinicaltrials.gov if one exists for that condition.

Some of the studies listed may use fetal or embryonic cells and we include them because efficacy may be similar with the adult mesenchymal umbilical cells we use, but we wish to emphasize that we do not use fetal or embryonic cells for any of our patients.

Please contact us with any questions regarding these or other conditions at care@thepsci.com or 847-699-6810 x207.


ALS

Click here for the clinical trial for ALS


Ankylosing spondylitis


Anti-Aging

Click here for the clinical trial for Anti-Aging


Autism

For reference:

CARS/ABC: no autism <30, mild/moderate = 30-36.5, severe >36.5

CGI-SI: 1=normal, 7=severe

ATEC: 0-180, 180=severe

Click here for the clinical trial for Autism


Bell's Palsy/ Trigeminal Neuralgia

  • A preliminary report on stem cell therapy for neuropathic pain in humans
    Dr. Vickers enrolled 10 patients diagnosed with trigeminal neuralgia. Each patient had roughly 100-200g of tissue harvested by tumescent liposuction. The tissue was subsequently digested by colleganse and each patient received an average of 77 million total cells. The SVF was injected into the center or origin of pain, along with the adjacent pain field of the affected branches of the trigeminal nerve.  On a scale from 1-10, the average pain score before treatment was 7.5. 6 months after treatment the pain scores significantly improved to an average of 4.3. 5/9 reported decreased reliance on Gabapentin medication.   SVF with an average of 77 million total cells injected directly into the area of pain demonstrated the ability to significantly decrease pain scores and reduce reliance on neuropathic medication.
  • Seffer I, Nemeth Z. Recovery from Bell Palsy after Transplantation of Peripheral Blood Mononuclear Cells and Platelet-Rich Plasma. Plast Reconstr Surg Glob Open. 2017 Jun 29;5(6):e1376. doi: 10.1097/GOX.0000000000001376. PMID: 28740784; PMCID: PMC5505845.
    Single patient treated with bell’s palsy treated with plasma blood mononuclear cells and PRP locally injected along the distribution of the affected facial nerve. Treatment was repeated 9 times within a year. After completion of the regimen, the patient had significant improvement in the voluntary motion of facial muscles. There was significant improvement in facial contouring and the facial asymmetry was significantly reduced. She was able to completely close her left eye and 80% close her right eye. Plasma blood mononuclear cells and PRP demonstrated significant improvement in facial spasticity associated with bell’s palsy.

Cerebral palsy

  • Effect of Autologous Cord Blood Infusion on Motor Function and Brain Connectivity in Young Children with Cerebral Palsy: A Randomized, Placebo-Controlled Trial
    63 patients diagnosed with CP were enrolled in Dr. Sun’s study. These patients were randomized to receive ACB (N=32) or placebo (N=31) and then there was a crossover between infusions at 1 year. These patients were further stratified into high infused cell dose (>2x10^7 total nucleated cells) or low infused cell dose (<2x10^7 total nucleated cells) and they received these doses intravenously. When comparing the experimental and placebo groups, there was no significant difference in the Gross motor function measure (GMFM) at 1 year. When stratifying based off infusion dose, the group receiving the high dose infusion demonstrated statistically significant improvement in GMFM at 1 year (+4.3), compared to low dose (-1.9) and placebo (+2.2). The patients who received the high dose infusion also demonstrated statistically significant improvement in normalized whole brain connectivity. Both of these findings were demonstrated again after the crossover of patients occurred at 1 year after protocol initiation. This study suggests a dose dependent relationship in treating CP with autologous cord blood intravenously. Greater than 2x10^7 total nucleated cells was associated with improved gross motor scores and improved whole brain connectivity at 1 year. The low dose group did not show improvement compared to placebo.
  • Umbilical Cord Blood Therapy Potentiated with Erythropoietin for Children with Cerebral Palsy: A Double-blind, Randomized, Placebo-Controlled Trial
    In Dr. Min’s study, 96 patients with CP were enrolled and split into three cohorts. Group one received at least 3x10^7/kg total nucleated cells of allogeneic umbilical cord blood intravenously with two doses of 500 IU/kg recombinant human EPO, group 2 received 500 IU/kg EPO only and group 3 received placebo. The group receiving the allogeneic umbilical cord blood demonstrated statistically significant improvement compared to the other two groups in Gross Motor Performance Measure and BSID-II Mental and Motor scores at 3 and 6 months after treatment.   At 6 months the mean difference in GMPM between the allogeneic umbilical cord group was 5.34 and 4.95 when compared to the EPO and control groups, respectively. This study demonstrates that intravenous allogeneic umbilical cord cells at a dose of 3x10^7 total nucleated cells when combined with EPO showed significant improvement in gross motor ratings at 3 and 6 months; EPO alone was ineffective.
  • A Randomized, Placebo-Controlled Trial of Human Umbilical Cord Blood Mesenchymal Stem Cell Infusion for Children With Cerebral Palsy
    Dr. Huang’s trial consisted of 54 patients with cerebral palsy who were split into two groups. Group one received 4 infusions, each consisting of 5x10^7 human umbilical cord blood mesenchymal stem cells intravenously and group two received placebo (.9% NS).  Statistically significant improvement was seen in the experimental group compared to the control group in the GMFM-88 at 3, 6, 12 and 24 months. By the three month follow up, the experimental group demonstrated improvement in all 5 parameters (lying, sitting, crawling, standing and walking). The change in total score proportion in GMFM-88  was 10.27 in the experimental group vs. 4.75 for the control group at the end of 1 year. The experimental group also demonstrated significant improvement compared to control on the Comprehensive Functional Assessment (CFA) at 3, 6, 12 and 24 months. The change in total score in CFA was 18.9 in the experimental group vs. 8.07 in the control group at the end of one year.  Repeat intravenous infusions of umbilical cord mesenchymal stem cells at a dose of 5x10^7 resulted in significant gross motor and comprehensive functional assessment improvement compared to placebo at 1 year.
  • Therapeutic evidence of umbilical cord-derived mesenchymal stem cell transplantation for cerebral palsy: a randomized, controlled trial
    Dr. Gu’s trial consisted of 39 patients with cerebral palsy. 19 of the patients received four doses of 5x10^7 human umbilical cord mesenchymal stem cells intravenously along with standard physical therapy. The other 20 patients received 50ml of NS with 1% human serum albumin along with standard therapy. The experimental group demonstrated statistically significant improvement in ADL compared to the control group at 3 (+12.4 vs +5.97), 6 (+21.1 vs +10.1) and 12 (+23.0 vs +12.8) months. Additionally, there were significant differences between groups in the comprehensive functional assessment at 3 (+17.9 vs +7.4) and 6 (+23.8 vs +11.9) months. The gross motor functional measure improvement significantly differed at 6 (+59.0 vs +28.9) and 12 (+ 64.5 vs +36.8) months.  Repeat intravenous infusions of umbilical cord mesenchymal stem cells at a dose of 5x10^7 resulted in significant improvement in ADL, comprehensive functional assessment and gross motor compared to placebo at 12 months.
  • Comparative analysis of curative effect of bone marrow mesenchymal stem cell and bone marrow mononuclear cell transplantation for spastic cerebral palsy
    Dr. Liu enrolled 105 patients with cerebral palsy and these patients were divided into three groups. Group 1 received cultured autologous Bone marrow mesenchymal stem cells, group 2 received autologous bone marrow mononuclear cells and group three only received standard therapy. For the first two groups, the patients received four cell transplants, each cultured and consisting of 1x10^6 cells intrathecally. At 6 and 12 months, GMFM demonstrated significant improvement in the BMSC group compared to the other two groups. At 12 months, the GMFM was 127, 111 and 102 for the BMSC, BMMNC and control groups, respectively.  Additionally, at 6 and 12 months, the BMSC group demonstrated significant difference from the other 2 groups in fine motor functional measurement. The FMFM scores after 12 months were 79, 53 and 8 for the BMSC, BMMNC and control groups, respectively.  Repeat intrathecal injection of 1x10^6 autologous bone marrow derived mesenchymal stem cells showed significant improvement at 1 year in gross motor and fine motor ratings compared to patients who received the same dose of bone marrow derived mononuclear cells and control groups.
  • Outcomes of autologous bone marrow mononuclear cells for cerebral palsy: an open label uncontrolled clinical trial
    In Dr. Nguyen’s study, 40 patients with cerebral palsy were treated with two doses of bone marrow mononuclear cells injected intrathecally. The first treatment consisted of 27.2 x 10^ 6 mononuclear cells and 2.6x10^6 CD34+ cells. The second treatment three months later contained 17.1x10^6  mononuclear cells and 1.7x10^6 CD34+ cells. Patients demonstrated statistically significant improvement at 3 months and 6 months in all the parameters if the GMFM-88 and the modified ashworth score. The average GMFM-88 was 16.7 at baseline and increased to 38.9 at 3 months and 41.8 6 months after transplantation. The Modified ashworth score decreased from an average of 3.4 at baseline to 2.1 at 3 months and 2.0 after 6 months. Repeat intrathecal injection of bone marrow mononuclear cells demonstrated significant improvement in motor function and measures of spasticity at 6 months when compared to baseline.
  • Improvement in gross motor function and muscle tone in children with cerebral palsy related to neonatal icterus: an open-label, uncontrolled clinical trial
    In Dr. Thanh’s study, 25 patients were treated with intrathecal autologous bone marrow aspirate mononuclear cells in an attempt to treat cerebral palsy.  The patients received 17.4x10^6  mononuclear cells and 1.5x10^6 CD34+ cells in the first treatment and 6 months later in the second treatment received 15x10^6 and 1.1x10^6, respectively. All parameters of the GMFM-88 improved significantly at both 6 months and at 12 months. The overall average GMFM-8 at baseline was 18.3. This increased to 35.8 after 6 months and 53.2 after 12 months. The ashworth score also improved significantly 6 months and 12 months post-transplantation.  The initial Ashworth score was 4.0 at baseline and decreased to 3.3 after 6 months and 3.0 after 12 months. Repeat intrathecal injection of bone marrow mononuclear cells demonstrated significant improvement in motor function and measures of spasticity at 6 and 12 months when compared to baseline.
  • Treatment of Cerebral Palsy with Stem Cells: A Report of 17 Cases
    17 patients with CP were enrolled in this study. Each patient received roughly two million bone marrow mononuclear cells per kilogram of body weight intrathecally. Progress was determined by the Gross Motor Function Classification Scale (GMFCS). 11/15 patients demonstrated an improvement of GMFCS, with an overall average increase of 1.3 points. None of the patients regressed on this scale during the study period. There was also a cognitive function assessment, for which 40% of the patient population demonstrated improvement throughout the study period.  Intrathecal injection of bone marrow mononuclear cells at a dose of two million per kilogram demonstrated improvement in gross motor and comprehensive function assessment compared to baseline.

Click here for the clinical trial for Cerebral Palsy


Chronic Obstructive Pulmonary Disease


Cleft Lip and Palate

  • Two doctors from the Maimonides University in Buenos Aires, Guillermo Trigo and Gustavo Moviglia, are the first to recover missing tissues caused by cleft lip and cleft palate through the use of stem cells, reported the Cord Blood Bank in a statement.

Read more


Diabetes

Dr. Hu’s clinical trial enrolled 29 patients with type 1 diabetes, 15 of which were treated and 14 were used as controls. The patients randomized to the experimental group received an average of 2.6x10^7 of cultured Wharton’s Jelly Mesenchymal Stem Cells intravenously.  From 9 months to 24 months, the experimental group demonstrated statistically significant improvement in postprandial glucose levels compared to the control group.  Additionally, the experimental group demonstrated statistically significant improvement compared to the control group from 9 to 24 months after treatment in HgbA1c levels. At the end of the follow up period, 11/15 patients in the experimental group either no longer required insulin therapy or had a dose reduction greater than 50%. In the control group, 7/14 required a dose increase greater than 50% at the end of the trial period compared to baseline. Intravenous cultured wharton’s jelly mesenchymal stem cells at a dose of 2.6x10^7 demonstrated significant improvement compared to the control group at the end of the 24 month study period in postprandial glucose levels, HgbA1c levels and in reduction of daily insulin requirements.   

Dr. Jiang’s clinical trial enrolled 10 patients with type 2 diabetes. They were treated with 3 doses with a one month interval between treatments with a total of 1.35x10^6 placenta derived mesenchymal stem cells per kg intravenously. All patients were followed for 3 months. A daily mean dose of insulin was reduced from 63.7 to 34.7 and 4/10 patients had a reduction of >50% of daily insulin usage. The average C-peptide for the 10 patients was increased from 4.1 to 5.6. Repeat treatment of 1.35x10^6/kg of placenta derived mesenchymal stem cells administered intravenously demonstrated significant improvement in reduction of daily insulin requirement and average C-peptide level for at least 3 months.

Dr. Cai’s clinical enrolled 42 patients with type 1 diabetes. 21 patients were allocated to the experimental group and 21 patients were assigned to the control group. The treated group was given 1.1x10^6 cultured umbilical cord cells per kilogram and 106.8x10^6 bone marrow mononuclear cells per kilogram, administered directly into the dorsal pancreatic artery. After 12 months, the AUC-Cpeptide increased 105.7% in the experimental group (6.6 to 13.6). The AUC-cpeptide decreased 7.7% in the control group (8.4 to 7.7). The AUC-Insulin increased 49.3% in the experimental group (1477 to 2205), while decreasing 5.7% in the control group (1517 to 1431). HgbA1c decreased 12.6% in the experimental group (8.6 to 7.5) while it increased 1.2% in the control group (8.7 to 8.8).  Infusion of 1.1x10^6 cultured umbilical cord cells combined with 106.8x10^6 bone marrow mononuclear cells per kilogram directly into the dorsal pancreatic artery showed significant improvement of C-peptide, endogenous insulin production and HgbA1c after 12 months compared to control group.

Dr. Mesples study enrolled 134 patients diagnosed with Type 1 DM. The patients received 5 - 10 mg/kg/day of filgrastim subcutaneously for 4 days. On the 5th day bone marrow was aspirated, no culturing occurred. The patients received  CMN > 1 × 120 and CD34+ > 0.37 × 10.6/kg intravenously. At onset of the study, all 134 patients had c-peptide levels less than .5ng/ml. At one year follow up, 34 patients had c-peptides below .5ng/ml, 50 patients had c-peptides between .5 and .9ng/ml and 50 patients had c-peptides above .9ng/ml. Initially, 28 patients were receiving greater than 40 units of Insulin daily and there weren’t any patients were receiving no insulin. After 1 year, only 3 patients were receiving more than 40 units and 60 patients were receiving no insulin. Initially, only 25 patients had A1c levels less than 7 and 21 patients had A1c levels above 9. After 1 year, 90 patients had A1c levels less than 7 and only 3 patients had A1c levels above 9. Filgastrim treatment followed by bone marrow aspiration and intravenous reinfusion demonstrated the ability to significantly increase c-peptide levels, decrease total insulin requirement and significantly improve HgbA1c levels 1 year after treatment.

Dr. Bhansali’s study enrolled 30 patients diagnosed with type 2 diabetes. 10 patients were treated with 1 million autologous bone marrow derived mesenchymal stem cells per kilogram and 10 patients were treated with about 1 billion autologous bone marrow mononuclear cells. Both of these cell loads were infused directly into the superior pancreaticoduodenal artery. An additional 10 patients underwent a sham procedure. The primary endpoint was a reduction in insulin requirement by greater than 50% from baseline, while maintaining HbA1c <7.0%. Both of the experimental had 60% of patients reach the primary endpoint, while the control group had 0% reach the primary endpoint. Injection into superior pancreaticoduodenal artery of bone marrow mononuclear cells and bone marrow mesenchymal stem cells demonstrated superior efficacy in reducing insulin requirement while maintaining a low HgbA1c compared to placebo 1 year after treatment.  

Dr. Liu’s study enrolled 22 patients with T2DM. The patients received two doses of Wharton’s Jelly Mesenchymal Stem Cells, each at a dose of one million cells per kilogram body weight. The first dose was delivered intravenously and the second dose, 5 days later, was delivered into the splenic artery. HgbA1c showed significant improvement at 1 month, 3 months, 6 months and 1 year after treatment. Baseline HgbA1c average was 8.2 and the average was 7.0 at 12 month follow up. 2 hour postprandial glucose also demonstrated significant improvement at 1, 3, 6 and 12 months after treatment. Baseline postprandial glucose was 14.96 and this decreased to 12.25 at 12 months. Additionally, the patients receiving Insulin therapy showed a statistically significant dose reduction at 1, 3, 6 and 12 months compared to baseline. Wharton’s Jelly mesenchymal stem cells demonstrated significant improvement in HgbA1c, postprandial glucose levels and insulin dose requirement at 1, 3, 6 and 12 months when compared to baseline.

Click here for the clinical trial for Diabetes


Erectile dysfunction and Peyronie's Disease


Eye disease


Fractures

49 patients with tibial nonunion received bone marrow aspirate concentrates injection with demineralized bone matrix and/or recombinant human bone morphogenic protein-2. Patients were observed until they reached radiographic healing (bridging of ¾ cortices on AP and lateral films) or underwent another procedure. The use of recombinant human bone morphogenic protein-2 was associated with lower healing rate as compared to demineralized bone matrix. Early intervention was associated with higher union rates.

6 patients with chronic fracture non-unions received autologous mesenchymal stem cells injected percutaneously. This method of treatment may be an alternative for non-operative treatment recalcitrant non-union fractures.

24 patients with distal tibial fractures were randomized into a control group and a group receiving MSCs and PRP mixed with demineralized bone matrix. The median time to fracture union was 1.5 months in the intervention group and 3 months in the control group.

20 patients with mandibular angle fractures were divided into 2 groups: study group fracture reduction plus autologous mesenchymal stem cells and study group fracture reduction alone. Similar ossification rates were observed for each group after 4 weeks but after 12 weeks, the MSC group had a higher ossification rate.


Heart Failure

26 patients who underwent PCI for acute anterior wall ST segment elevation myocardial infarction were included in this study. 12 patients were assigned to the control group and 14 patients received 7.2x10^7 cultured autologous bone marrow derived mesenchymal stem cells administered through a perfusion catheter 1 month after PCI. 4 months after treatment, the experimental group had an increase in LVEF of 8.8% and the control group had an increase of 4.8%. At 12 months after treatment, the experimental group had an increase in LVEF of 9.9% while the control group had an increase of 6.5%. Cell therapy was not related to an increase in any adverse events. Administration of cultured autologous bone marrow derived mesenchymal stem cells via a perfusion catheter increased LVEF at 4 and 12 months compared to control, without any cell related serious adverse events.

60 patients with ischemic heart failure were enrolled in this study. 20 patients were used as controls and 40 patients received intramyocardial injections of cultured autologous bone marrow derived mesenchymal stem cells. Patients were treated with an average of 77.5x10^6 MSCs. After 12 months, LVESV was significantly reduced in the MSC group and not in the placebo group, with a difference between groups of 17.0mL. There was also a significant difference between groups of 6.2% in LVEF, 16.1mL of stroke volume and significant difference in myocardial mass. A significant dose response curve was observed, with greater amount of stem cells providing greater efficacy. Significant improvements in amount of scar tissue as well as quality of life indexes were seen in the experimental group, but not in the control group. Intramyocardial injection of autologous bone marrow derived mesenchymal stem cells resulted in significant improvement in LVESV, LVEF, scar tissue and quality of life compared to placebo at 12 months.

Patients suffering from heart failure with reduced ejection fraction were enrolled in this study. 15 patients were used as control and the other 15 patients received 1x10^6/kg cultured allogeneic umbilical cord derived mesenchymal stem cells administered intravenously. No treatment related adverse events were observed. Echocardiograph after 12 months showed significant differences in the improvements of LVEF with a 7.07 increase in the experimental group and a 1.85 in the control group. Additionally, patients in the experimental group showed improvements in the NYHA class and MLHF questionnaire, whereas the control group did not. Intravenous administration of cultured allogeneic umbilical cord derived MSCs resulted in significant improvement in LVEF, NYHA class and MLHF questionnaire at 12 months compared to the placebo group.

22 patients with nonischemic cardiomyopathy were enrolled in this study. 10 patients initially received intravenous administration of 1.5x10^6/kg cultured allogeneic bone marrow derived mesenchymal stem cells and the other 12 received placebo. After 90 days, the two cohorts switched. There were no treatment related serious adverse events. Compared with placebo, MSC therapy increased 6 minute walk distance, Kansas City Cardiomyopathy clinical summary and functional status score. No significant differences were noted in LVEF or ventricular volume. Intravenous administration of cultured allogeneic bone marrow derived mesenchymal stem cells resulted in improved 6 minute walk test, Kansas city cardiomyopathy clinical summary and functional status score. No treatment related serious adverse events.


Idiopathic Pulmonary Fibrosis

  • First‐in‐human high‐cumulative‐dose stem cell therapy in idiopathic pulmonary fibrosis with rapid lung function decline
    Alexander Averyanov
    Dr. Averyanov’s phase I/IIa clinical trial enrolled 20 patients, 10 of which received treatment and the other 10 received placebo. The treatment group received two IV doses of cultured 2x10^8 allogeneic bone marrow MSCs every 3 months for a total of 12 months.  At the end of the 12 month study period, the experimental group had a 3.7% FVC increase from baseline while the placebo group had a 9.5% decrease from baseline. The experimental group had an increase of 24.2% in the 6MWTD while the placebo group had a 9.8% decrease. The experimental group had a 5.1% decrease in DLCO while the placebo group had a 12.9% decrease, demonstrating significant improvement in all 3 parameters.  Repeat allogeneic bone marrow mesenchymal stem cells administered intravenously demonstrated significantly improved FVC, DLCO and 6MWTD at 12 months compared to the control group.
  • Intravenous stem cell dose and changes in quantitative lung fibrosis and DLCO in the AETHER trial: a pilot study
    J E Fishman
    Dr. Fishman’s phase 1 clinical trial treated 6 patients with mild to moderate IPF. These 6 patients were separated into two cohorts. Cohort 1 received single infusion of 2x10^7 allogeneic  bone marrow derived mesenchymal stem cells intravenously and Cohort 2 received single infusion of 1x10^8 bone marrow derived mesenchymal stem cells, intravenously. From baseline to 48 weeks cohort 2 demonstrated statistically significant better results than cohort 1 in quantitative lung fibrosis (+1.13% vs +4.00%), forced vital capacity (-3.84L vs -5.85L), total lung capacity (+9.95L vs –1.24) and Diffusing Capacity of Lung for Carbon Monoxide (-2 vs -17). This study demonstrated a dose dependent improvement for allogeneic bone marrow derived mesenchymal stem cells administered intravenously in quantitative lung fibrosis, FVC, TLC and DLCO, with the higher dose demonstrating significant improvement compared to the low dosage group 2 years after treatment.

Click here for the clinical trial for Idiopathic Pulmonary Fibrosis


Inflammatory Bowel Disease

Crohn's Disease

Ulcerative Colitis

Click here for the clinical trial for Inflammatory Bowel Disease


Interstitial Cystitis

109 patients with interstitial cystitis were included in this study. Patients underwent lipoaspirate and received SVF administered intravenously and injected regionally into the pelvic floor muscles. Overall, average pain scores from baseline decreased from 5.14 to 3.67 at 12 months. The Pelvic pain and urgency/frequency patient symptom scale also improved from 21.42 to 14.2 at 12 months. Intravenous and regional administration of SVF resulted in significantly decreased pain and improved symptom rating scale when reassessed 12 months after treatment.

20 rats included in this study and had outlet obstruction surgically induced and then treated with intravenous injection of bone marrow derived mesenchymal stem cells. By two weeks after treatment there was significant reduction in TNF-alpha and increase in IL-10 and VEGF. By 4 weeks after treatment there was significant downregulation in profibrotic genes. End filling pressure, hypertrophy and fibrosis were all significantly reduced after 4 weeks. Intravenous injection of bone marrow derived mesenchymal stem cells resulted in anti-inflammatory cytokine preference and decreased filling pressure, bladder hypertrophy and bladder fibrosis after 4 weeks.

Rats with induced interstitial cystitis included in this study.  Rats were treated with either urine derived MSCs, adipose derived MSCs, bone marrow derived and amniotic fluid-derived MSCs. Additionally, all groups had participants with routes either direct into the bladder mucosa, into the tail vein, or transurethral installation. Reassessment was performed 10 days after treatment. Intercontraction interval was significantly increased and inflammatory reactions/fibrotic changes were decreased in all of the stem cell injected groups compared to the control group. PCR revealed significantly decreased fibrotic gene expression in the urine derived stem cell group compared to the others. The groups that received stem cells administered directly into the bladder submucosa showed significantly longer intercontraction interval, better morphological regeneration and inhibition of bladder inflammatory reaction compared with the other groups. Administration of stem cells increased intercontraction interval and decreased inflammatory changes of rats with induced interstitial cystitis. Urine derived stem cells showed the greatest reduction in fibrotic gene expression. Direct injection into the bladder submucosa showed greater clinical efficacy than alternative routes of administration


Kidney Disease

Click here for the clinical trial for Kidney Disease


Leg and foot ulcer


Lupus

Click here for the clinical trial for Lupus


Multiple Sclerosis

Click here for the clinical trial for Multiple Sclerosis


Multiple System Atrophy

24 multiple system atrophy patients received between 10 and 200 million adipose derived autologous MSCs delivered intrathecally. There were no serious adverse events. At the highest dose, ¾ patients experienced leg pain and it was determined that dose-limited toxicity was reached. The rate of progression of disease was lower for the MSC groups as compared to historical control, but more studies should be conducted.

33 patients with multiple system atrophy (cerebellar type) were randomly assigned to receive either 40 million MSCs intra-arterially or intravenously or a placebo. The MSC group had a smaller increase in UMSARS part II scores compared to placebo. This indicates that MSC treatment could delay the neurological deficit progression in MSA.

11 patients were treated with MSCs for multiple system atrophy, compared to 18 patients treated with a control. The MSC patients had significantly higher improvement than the control patients. MSC treatment delayed the progression of neurological deficits in MSA patients.


Osteoarthritis

12 patients underwent autologous adipose-derived MSC treatment, injected intra-articularly into 12 knees. 12 knees were injected with saline, acting as the control. A single injection led to significant WOMAC improvement at 6 months. There was no significant WOMAC improvement in the control group. There was no significant change in cartilage defect for the MSC group after 6 months while there was a significant increase in defect for the control group after 6 months. This study demonstrates that intra-articular injections of MSCs for knee osteoarthritis significantly improves pain scores and prevents continued cartilage defect.

30 patients with knee osteoarthritis were divided into 3 groups. 2 treatment groups received an intra-articular injection of adipose derived MSCs (either one dose of 1 million cells at baseline or a dose of 1 million cells at baseline and an additional dose of 1 million cells after 6 months). The third group underwent conservative management, serving as a control. The MSC groups both showed clinically significant pain reduction and functional improvement at the 12 month follow up.

18 patients with knee osteoarthritis were enrolled in this study. Phase one of the study had 3 groups of 3 patients, receiving either a low dose (1x10^7 cells), mid-dose (5x10^7 cells), or high dose (1x10^8 cells). The second phase enrolled 9 patients all receiving the high dose. After 6 months, the high-dose group experienced significant improvement in pain and knee function.

30 patients with knee osteoarthritis were assigned to receive either intra-articularly administered HA, HA plus 1 million bone marrow MSCs, or 100 million bone marrow MSCs alone. No adverse events were reported at the 4 years follow up. The bone marrow MSCs group had clinically significant improvements in WOMAC.

57 subjects were randomized into 4 different groups: one group receiving a hyaluronic acid control and 3 groups receiving doses of adipose derived stem cells. At the week 24 follow up, both groups had improvements in WOMAC score but the stem cell group also had significant improvements after 4 weeks. The stem cell group pain scores after 48 weeks suggest a longer duration of effectiveness compared to the HA group.

Patients were randomized to receive either HA at baseline and 6 months, a single dose of 20 million umbilical cord MSCs at baseline, or 2 doses of 20 million umbilical cord MSCs at baseline and 6 months. The MSC-treated patients experienced significant improvements in pain and function from baseline while the HA group did not. The pain score for the 2-dose group was significantly lower than the HA group at 12 months.


Parkinson’s Disease


Rheumatoid arthritis

Click here for the clinical trial for Rheumatoid Arthriris


Sarcoidosis


Scleroderma

Dr. Granel followed 12 patients diagnosed with systemic sclerosis. The patients were treated with autologous adipose derived-SVF at a dose of 3.78x10^6 cells administered directly into each finger. Conchin Hand Function Scale showed a significant improvement of 47.4% at 2 months and 56% at 6 months. Grip strength and pinch strength at 6 months showed a significant improvement in both dominant and non-dominant hands. The global modified rodnan skin score decreased significantly at 2 and 6 months when compared to baseline. Raynoud Condition Score and hand pain also showed statistically significant improvement at 2 and 6 months, Injection of SVF directly into the digits in patients with scleroderma demonstrated efficacy in improving function, strength, skin thickness, raynoud’s symptoms and pain at 2 and 6 months.

Dr. Guillaume-Jugnot’s clinical trial followed 12 patients for 12 months after treatment with SVF injected into the subcutaneous tissue of each digit. From the lipoaspiration, an average of 50.5x10^6 total viable nucleated cells was obtained. At 12 month follow up, Conchin Hand Functional Scale, Raynoud Condition Score, hand strength, mean circumference of fingers and pain scores all demonstrated statistically significant improvement. Injection of SVF into the subcutaneous space of the digits resulted in significant functional improvement and pain reduction in patients with scleroderma when evaluated 12 months after treatment.  

Dr. del Papa’s study enrolled 38 patients with digital ulcers secondary to systemic sclerosis. 25 were treated with .5-1mL of autologous adipose tissue injected at the base of the finger that had the ulcer. The other 13 patients underwent sham procedures. 92% of patients in the treatment group demonstrated distal ulcer healing after 8 weeks. This was compared with only 7.7% of patients who had healing ulcers in the control group. The difference was highly statistically significant. After 8 weeks, all 12 patients who had ulcers in the control group that did not heal received the treatment therapy. In the following 8 weeks, all 12 of these patients had evidence of ulcer healing. Treatment was also associated with a significant reduction in pain scores and also was significantly associated with increased capillaries in the affected digits. Injection of autologous adipose tissue into the base of a digit with a distal ulcer demonstrated increased healing, reduced pain and increased capillary number within 8 weeks compared to placebo.

Click here for the clinical trial for Scleroderma


Sjogren’s Syndrome

24 patients with sjogren’s syndrome were enrolled in this study and treated with an intravenous infusion of 1x10^6/kg cultured allogeneic umbilical cord derived mesenchymal stem cells. No serious adverse events occurred. All patients showed improvement, with a response time ranging from 2 weeks to 6 months. At 12 months, 83% of patients had their sjogren’s syndrome disease activity index decrease by greater than 30% from baseline. At 12 months, 75% of patients’ VAS score decreased by greater than 30%. Patients suffering from specific disease processes including decreased salivary flow rate and organ specific involvement showed significant improvement in salivary flow rate and organ specific indexes within the 12 month follow up. The only organ system not to show significant improvement was the nervous system. Intravenous infusion of allogeneic cultured umbilical cord derived mesenchymal stem cells resulted in significant improvement in pain and disease activity indexes. All organ systems involved showed significant improvement, except the nervous system. No treatment related adverse events occurred.


Spinal Cord Injury with Paralysis


Traumatic brain injury

Click here for the clinical trial for Traumatic brain injury