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FAQs

Licensure

Are you licensed to perform stem cell treatment in Antigua?

Yes, we are licensed under the Antigua Stem Cell Therapy and Research Act of 2019 which has legal jurisdiction in Antigua, as the FDA does in the United States.

Definitions

What are mesenchymal stem cells?

  • Partially differentiated stem cells that are active in tissue repair. They help tissues heal themselves. They modulate the immune system and decrease inflammation.
  • We only use mesenchymal stem cells (MSC) from Vitro Biopharma in Golden, Colorado. They are cGMP and FDA-registered and approved for use in human subjects. These are NOT fetal or embryonic. Rather women donate their umbilical cords after term Cesarean sections. After testing, the stem cells are isolated from the umbilical cord, and the donors and cells are tested, including their DNA. They are expanded in culture and cryopreserved until immediately before use so they are kept fresh.

Some of the Disorders We Treat

What are stem cell injections used for?

  • Arthritic joints as an alternative to joint replacement
  • Back and neck pain
  • Anti-aging
  • Neurologic diseases such as multiple sclerosis and Parkinson’s disease
  • Inflammatory bowel disease: ulcerative colitis and Crohn’s disease
  • Rheumatoid arthritis and lupus
  • Spinal cord injury and post-stroke
  • Long COVID
  • Polycystic ovary syndrome
  • Infertility
  • Psoriasis and other skin disorders
  • Pulmonary fibrosis and COPD
  • Erectile dysfunction, Peyronie’s disease and interstitial cystitis
  • Lyme disease
  • Chronic fatigue
  • Scleroderma
  • Most autoimmune or inflammatory disorders

Results

How effective are stem cells for these disorders?

Results vary by disease. For some disorders, they are very effective. For others at this time their effect may be small or only effective early in the disease. For arthritis, most patients are treated successfully and are able to avoid joint replacement surgery.

How many treatments are needed?

For many disorders, one treatment will last for years. In some cases, treatment must be repeated more often.

How long does it take for treatment to work?

Results are seen within a week for many disorders, although results can take 3-6 months to occur.

Are there any diseases where stem cells have not been shown to work so far?

In general, genetic disorders such as Cystic Fibrosis, Huntington’s Chorea, and Duchenne Muscular Dystrophy are not benefited by stem cells. There has also been little to no success with Alzheimer’s Disease. However, stem cell treatment combined with gene editing shows great promise for the future.

Autologous versus Allogeneic

What do autologous and allogeneic mean?

  • Autologous means it comes from the patient being treated
  • Allogeneic means it comes from someone else

Do you use autologous or allogeneic cells?

We usually use allogeneic umbilical cord-derived stem cells from Vitro Biopharma in Golden, Colorado. Sometimes, we use autologous adipose-derived cells from the patient themself. 

Risks

Are there risks/complications of mesenchymal stem cell injections?

Stem cell treatment is arguably one of the safest treatment paradigms that exists. There are no medication side effects and no surgical complications. We have completed a systematic literature review submitted for publication showing no severe adverse events ever reported for stem cell treatment for arthritis for example. Two other papers have excellent safety for intravenous and intra-thecal (spine) injections. A paper we have written currently in pre-publication peer review has also shown to tumorigenicity. There is a theoretical risk of infection anytime an injection takes place although we have never seen one. Stem cell injections are actually used to help fight infections. Minor side effects such as transient local pain, chills, mild headache, and lightheadedness may be seen.

Are there serious adverse events after stem cell injection?

Out of thousands of reported injections: no infections, tumors, or other serious adverse events have been reported in the entire PubMed-indexed (The National Library of Medicine index of roughly ~30,000 high-quality medical journals) medical literature for intravenous, intra-thecal (spine-nervous system) or intra-articular (into a joint) mesenchymal stem cell injections except one report of simple arm venous thrombosis in China that resolved without problems.

Do these umbilical cord-derived cells cause rejection?

No. These cells lack the major histocompatibility type-two antigens which cause rejection of other types of cells but not these. Therefore, no tissue matching or testing is necessary with the recipient patient.

Can I be treated with stem cells if I am on blood thinners or other medicines?

Yes, patients should maintain all prior medications for stem cell treatment. Coumadin or other blood thinners are not a problem, except that all blood thinners including Aspirin must be discontinued in advance of back/neck injections. 

Benefits

Described below are some of the benefits of treatment we see. Not all patients benefit, and the degree of improvement varies. In general, we have data indicating how likely treatment will be to help from our research studies and our extensive knowledge of the medical literature. We do not accept patients for treatment for disorders where improvement has not been shown to occur, for example, many genetic disorders. Where there is pre-clinical (animal study) evidence of efficacy not yet shown in humans, and where the treatment has been shown to be safe, we conduct clinical studies at no charge, approved by our federally registered IRB through our 501c3 non-profit foundation (www.theforem.org). Full informed consent is obtained. We always attempt to fully apprise patients of all risks, benefits, and alternatives.

  • Anti-Aging: Studies done exclusively at our center show a decreased biological age in most patients 6 months after treatment. This is shown through improvements in DNA epigenetics – increased telomere length and DNA methylation improvements principally. It is also being shown with a more youthful brain on EEG; for example, we are finding an increase in para-sympathetic theta waves which generally go down with age naturally. This also promotes better sleep.
  • Improved Sleep: Most patients have substantial improvement in quality of sleep for prolonged periods after treatment. We are currently evaluating this with sleep studies.
  • Decreased Joint Pain: Patients with osteoarthritis, rheumatoid arthritis, and other joint disorders usually see a substantial decrease in joint pain.
  • Decreased Back/Neck Pain: This occurs in a majority of patients with a simple translaminar epidural and facet injections. Our large research paper is in peer review and awaiting publication.
  • Better Cognition: In those with “brain fog” and short-term memory loss, they are usually significantly improved. Many find focus also improved.
  • Decreased Parkinson's Symptoms: We have early exciting data as part of an ongoing clinical trial showing substantial improvement.
  • More Energy: Most of our patients with chronic fatigue before treatment are substantially improved after treatment.
  • Improved Mood: Many of our patients with neurocognitive diagnoses (e.g. Parkinson’s disease, essential tremor, tinnitus, and dementia) describe a feeling of calmness and improved mood and a feeling of well-being after treatment.
  • Decreased Gut Symptoms: Most patients with these issues find them significantly improved after treatment. 
  • Improved Breathing: Patients with asthma and COPD generally see an improvement in breathing.
  • Male Sexual Function: Patients with Peyronie’s and erectile dysfunction are often improved.
  • Female Hormonal Irregularities: Polycystic ovary syndrome and other ovarian/hormonal problems can be improved/
  • Improved Facial/Neck Skin: This may occur from simple intravenous infusion, but reliably occurs with stem cell application to the face.
  • Thicker Hair: This reliably occurs with scalp injections. 
  • Improved Hearing/Tinnitus/Eyesight: We have seen this with some patients very early in our free clinical trial. We will disseminate more information as we get further into the study.

Mechanism of Action

How do autologous mesenchymal stem cells work?

Via growth factors that help your tissue heal (e.g. transforming growth factor beta), platelet-derived growth factor). Also, via anti-inflammatory cytokines that fight inflammation. Their mechanism of action is immunomodulation. For example, they can help modulate your macrophage cells away from the M1 pro-inflammatory state to the M2 anti-inflammatory pro-healing state.

Technique

Who does the actual injection in your clinic?

All joint (e.g., knee, shoulder) injections are performed by Dr. Prodromos or another appropriate board-certified specialist. We do not have mid-level practitioners performing the injections as is the case at many clinics. Dr. Kenneth Candido MD, a world-renowned pain specialist from Chicago, performs our back injections in Antigua.

Do you use sedation or medications?

None are generally used, none are needed. In fact, we avoid them to eliminate possible medication side effects. However, sedation is available if needed.

Are the injections painful?

Injections in joints have some discomfort but it is minimal and usually far less than patients expect. Many patients are often surprised that the injection has been completed so easily. IV injections have no pain or other side effects in general. Occasionally a patient will feel transiently flushed or lightheaded or have a mild transient headache.

Side Effects

What side effects are seen from an injection of cells?

Some patients get a mild headache which generally resolves within an hour sometimes with Tylenol. Most patients do not get a headache. Some patients get shaking chills which generally resolve quickly. We provide heating blankets if this occurs. Most patients do not get shaking chills.

How do patients feel after stem cell injection?

Most patients feel a little fatigued on the day of injection. When this occurs, it resolves by the next day. Some patients do not. Some patients have more energy after injection. Within a day most patients feel quite good. Many feel a significant rejuvenative effect immediately or within days of IV infusions. Patients with joint injections feel soreness in their joints that gradually resolves in most cases within a week but may take longer.

The Future

Do you have new studies advancing the field? 

We do, and this is the hallmark of our institute. We are just scratching the surface of what can be accomplished.

Will this treatment be available in the USA?

Eventually it will and we have begun FDA-authorized studies to bring this about. However, the studies require extensive funding and take many years to complete. In the meantime, by accumulating positive treatment data we attempt to demonstrate the safety and efficacy of stem cell treatment.