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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.

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

ALS

ADULT MESENCHYMAL STEM CELL STUDIES SHOWING EFFICACY IN THE TREATMENT OF ALS AS OF 7/14/2021

Click here for the clinical trial for ALS

Ankylosing spondylitis

Stem Cell Efficacy for Ankylosing Spondylitis as of 8/10/21

Anti-Aging

STEM CELL EFFICACY FOR ANTI-AGING AS OF 8/2/21

Click here for the clinical trial for Anti-Aging

Autism

Stem Cell Efficacy for Autism as of 7/26/21

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
    Vickers (2014)
    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

    Children with Cerebral Palsy: A Randomized, Placebo-Controlled Trial
    Sun (2017) – California

    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

    Min (2013) – South Korea

    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

    Li Huang – China

    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

    Xuebin Liu – China

    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

    Liem Thanh Nguyen – Vietnam

    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

    Liem Nguyen Thanh – Vietnam

    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

    Chahine (2016)

    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

Stem Cell Efficacy for COPD as of 8/9/21

Cognitive and memory decline

References:

Diabetes

Clinical studies of mesenchymal stem cell treatment in the treatment of type 1 diabetes has shown promise. A study done by Hu et. al showed an improvement in DM1 patients treated with intravenous mesenchymal stem cells. This study showed an improvement in HBA1C and C-peptide levels. In line with some of this clinical data and clinical data from other autoimmune conditions, we believe that intravenous administration of mesenchymal stem cells can be an effective treatment for DM 1. Mesenchymal stem cells have also shown some efficacy in the treatment of type 2 diabetes. A study done by Jiang et al showed an improvement in DM2 patients treated with intravenous mesenchymal stem cells. This study showed positive results in treated patients with improvements in average blood insulin levels and C-peptide as well as improvements in renal and cardiac function[10].

References:

Click here for the clinical trial for Diabetes

Erectile dysfunction and Peyronie stem cell

Eye disease

Fractures

Clinical studies of mesenchymal stem cell treatment in the treatment of bone fracture have shown promise. A study done by Desai et al examined the effect of mesenchymal stem cell treatment on patients with nonunions or delayed union fractures. Using mesenchymal stem cells, this study achieved a 79.6% union rate and demonstrated union rate with an average healing time of 4.7 months. Another clinical study by Centeno et. al found treatment with mesenchymal stem cells improved healing in 4 of 6 patients with long term non-union fractures (up to 18 months of nonunion prior to treatment)[2]. In line with some of the preclinical data and clinical data from other autoimmune conditions, we believe that intravenous administration of mesenchymal stem cells Treatment for fractures.

References:

Heart failure

References:

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

IBD efficacy file as of 8/5/2021

CD

UC

Click here for the clinical trial for Inflammatory Bowel Disease

Interstitial Cystitis

Preclinical studies of mesenchymal stem cell treatment in the treatment of interstitial cystitis have shown promise. A study done by Song et. al showed an improvement in irregular and decreased voiding interval in an preclinical study of interstitial cystitis. The study also showed improvement in denudation of bladder epithelium and mast cell infiltration[9]. Another preclinical study by Ryu et al showed improvement in bladder voiding and histology. In line with preclinical data and clinical data from other inflammatory disorders, we believe that intravenous and/ or pelvic floor administration of mesenchymal stem cells can be an effective treatment for interstitial cystitis.

References:

Kidney Disease

Stem cell efficacy for renal failure as of 8/10/21

Click here for the clinical trial for Kidney Disease

Leg and foot ulcer

Stem Cell Efficacy for Leg Ulcers as of 8/10/21

Liver autoimmune hepatit

References:

Lupus

Lupus efficacy as of 12/13/21

Click here for the clinical trial for Lupus

Multiple Sclerosis

Click here for the clinical trial for Multiple Sclerosis

Multiple System Atrophy

References:

Osteoarthritis

References:

Parkinson’s Disease

Stem Cell Efficacy for Parkinson’s as of 7/21/21

Rheumatoid arthritis

Stem Cell Efficacy for RA as of 7/21/21

Click here for the clinical trial for Rheumatoid Arthriris

Scleroderma

References:

Click here for the clinical trial for Scleroderma

Sjogren’s Syndrome

Clinical and preclinical studies of mesenchymal stem cell treatment in the treatment of Sjogren’s syndrome have shown promise. A study done by Xu et. al showed an improvement in salivary gland inflammation and saliva flow rate in their preclinical animal model treated with mesenchymal stem cells. This study then went on to demonstrate in improvement in patient reported clinical scores as well as improvement in an unstimulated salivary flow in a clinical trial with mesenchymal stem cells. Another clinical study by Liu et. al showed Sjogren’s syndrome patients had an improvement in clinical scores and decreased auto-antibodies after treatment with intravenous mesenchymal stem cells. In line with some of this clinical data and clinical data from other autoimmune conditions, we believe that intravenous administration of mesenchymal stem cells can be an effective treatment for Sjogren’s syndrome.

References:

Spinal cord injury with paralysis

Stem Cell Efficacy for Spinal Cord Injuries as of 7/20/21

Scleroderma

Clinical studies of mesenchymal stem cell treatment in the treatment of Scleroderma have shown promise. A study done by Guillaume-Jugnot et. al showed an improvement in hand function, quality of life, finger edema, skin sclerosis, and hand motion/ strength in patients treated with digital subcutaneous mesenchymal stem cells[9]. In line with some of this clinical data and clinical data from other autoimmune conditions, we believe that intravenous and subcutaneous administration of mesenchymal stem cells can be an effective treatment for Scleroderma.

References:

Traumatic brain injury

Stem Cell Efficacy for Traumatic Brain Injury as of 7/26/21

Click here for the clinical trial for Traumatic brain injury