What Stem Cell Clinics Do You Trust?

This article explores leading stem cell centers within the U.S. and worldwide. Read on to learn about this emerging area of medicine.

Stem Cell Treatment Centers

Stem cell clinics have received a great deal of negative press, with prominent media outlets announcing that the Food and Drug Administration (FDA) had mailed “Warning Letters” to stem cell centers across the United States.

But, is this the whole story?

What this angle does not cover is the promising medical potential of stem cell therapies. It also does not acknowledge the large number of legitimate stem cell clinics that comply with FDA regulations to offer effective medical treatments to populations of patients who otherwise have limited options.

Many of these companies also collaborate with offshore regulatory bodies to offer stem cell procedures approved by local regulatory agencies.

FDA Compliant Stem Cell Treatment Centers

Today, the majority of medical clinics that offer stem cell treatments administer mesenchymal stem cells (MSCs), which they source from human fat (adipose tissue) or bone marrow.

Mesenchymal stem cells are a type of multipotent stem cell that is administered for a range of medical applications, including orthopedic repair, pain management, arthritis, and asthma. When properly administered, multipotent self-derived stem cells (such as MSCs) can be safe for patient use.

It is important that the cells be multipotent (limited in their differentiation capacity), rather than totipotent (can become any cell) or pluripotent (can become most cells). There is also an additional level of safety that comes from having stem cells be self-derived, which doctors and scientists call “autologous.”

While it is true that some stem cell centers are not following FDA regulations, the therapeutic promise of stem cells is also clear.

Today, an incredible 74,000+ scientific publications highlight research advances with mesenchymal stem cells (MSCs) and over 1,590+ clinical trials are investigating therapeutic uses of MSCs. Additionally,  an astounding 482,000+ scientific publications have been released about stem cells at large.

These are staggering numbers and provide highly evidence to confirm the therapeutic potential of stem cells.

Top Stem Cell Clinics

Below, six leading stem cell centers are presented. Each one has treated large populations of patients with adult stem cells. At least one (Regenexx) is maintaining a Patient Registry to document long-term patient outcomes.  Others, like GIOSTAR, have been working with the U.S. FDA on clinical trials related to the treatment of COVID-19.

Several of them, have been treating patients for over a decade.

Please note that we are not advising patients to seek treatment from these companies. We are identifying in this article to allow readers to seek out more information.

2. Stem Cell Institute (Panama)

• spinal cord injury (SCI)
• rheumatoid arthritis
• heart failure
• osteoarthritis
• multiple sclerosis
• autoimmune diseases
• genetic disorders, such as autism and cerebral palsy

One of their most recent studies exhibited the clinical feasibility of stem cell transplant process as a safe and effective treatment approach for patients with multiple sclerosis (MS).

Published in the Journal of Translational Medicine, the study showed that umbilical cord stem cells can slow down MS disease progression and decrease the frequency of flare-ups.

However, these stem cells did not exhibit the ability to repair damaged nerve cells or myelin sheaths.

After the completion of this clinical study, there was an improvement in MS patient disability. The 1-month mark of the study documented improvements in mobility, hand, bladder, bowel, and sexual functions. Importantly, the study demonstrated that a sustained one-year umbilical cord stem cell therapy has more durable benefits than current MS drug therapies.

3. Regenexx

Headquartered in Denver, CO, Regenexx offers self-derived (autologous transplant) same-day stem cell treatments to patients with orthopedic injuries and conditions. Regenexx clinics incorporate a variety of regenerative approaches, drawing patients from all over the U.S. who are seeking innovative, non-surgical treatments.

The Regenexx® technology involves a procedure in which a small bone marrow sample is extracted through a needle and blood is drawn from a vein in the arm. These samples are then processed in a laboratory and the cells they contain are injected into the area needing repair, with the goal of delivering large numbers of stem cells to the site of injury.

Regenexx is also a licensed offshore clinic in the Cayman Islands where patients can undergo treatments that utilize laboratory-expanded (“ex vivo”) stem cell populations. This approach allows for a much larger number of stem cells to be administered to the patient than is supported by U.S. law, which currently prohibits laboratory procedures that the FDA considers to exceed “minimal manipulation.”

Dr. Christopher Centeno is the Founder and CEO of Regenexx. He is a global authority in the culture expansion and clinical use of adult stem cells to treat orthopedic injuries and the visionary behind the Regenexx® technology.

I am also a Regenexx patient. Click here to read my experience.

4. DVC Stem

Headquartered in Seven Mile Beach, Grand Cayman, physicians at DVC Stem have been using complimentary alternative therapies to clinically treat patients with various medical conditions. It is one of the most advanced stem cell clinics in the Caribbean, with IRB-approved protocols, a fully licensed staff, and a facility that is accredited by the medical governing bodies of the Cayman Islands.

DVC Stem sources its cells from its partner lab Vitro Biopharma Inc, a state of the art, US-based, FDA registered, cGMP compliant and ISO 9001 certified laboratory, and only use American Association of Tissue Bank (AATB) certified suppliers of full-term, ethically U.S.-donated human umbilical cords.

Led by Medical Director Louis A. Cona, MD, DVC Stem’s focus is on cord-tissue derived allogeneic stem cell therapy for degenerative conditions, wear and tear, and intelligent aging.

Notable patients the company has treated include Lou Ferrigno (champion bodybuilder/actor), Michael Armand Hammer (businessman/philanthropist), and David Lyons (Founder, MS Fitness Challenge), and others .

5. Okyanos

Founded in 2011, Okyanos is a stem cell therapy provider that specializes in treating patients with congestive heart failure (CHF) and other chronic degenerative conditions. Okyanos Cell Therapy uses internationally-approved technology to deliver a mixed population of fat (adipose) derived stem and regenerative cells (ADRCs) to patients with conditions such as the following:

• cardiovascular disease
• orthopedic issues
• neurological disorders
• urological indications
• autoimmune conditions

Okyanos maintains both a North American Office in Clearwater, FL, and a purpose-built Cell Therapy Surgical Center in Freeport, Grand Bahama. Okyanos’ stem cell treatments are performed in their state-of-the-art surgical centers under the care of board-certified doctors.

Okyanos is also fully licensed and regulated under the Bahamas Stem Cell Therapy and Research Act and adheres to U.S. surgical center standards. Click here to read our interview with Matthew Feshbach, Co-Founder and CEO of  Okyanos.

6. Celltex

Celltex specializes in cryopreserving mesenchymal stem cells (MSCs) for therapeutic use. Celltex acquires stem cells by collecting a small fat sample from a patient, from which MSCs are extracted, isolated, multiplied, and stored for future use (known as cell banking).

Patients can then use their stored stem cells for regenerative purposes through infusions or injections performed by a licensed physician.

Because the FDA considers an individual’s stem cells a drug if they have been expanded in large quantities, Celltex has begun the process of undertaking clinical trials on stem cells as a treatment for a range of medical conditions, seeking approval from the FDA to allow physicians to utilize these cells.

Nonetheless, to meet the immediate needs of its clients, the company also has taken steps to meet the requirements of the FDA and COFEPRIS, a Mexican institution equivalent to FDA in MSCs import and export.

Celltex also works with Mexican hospitals that are established and certified that allowed the company’s cell-banking clients to receive their stem cells for medical purposes.

Questions to Ask Before Undergoing a Stem Cell Therapy

Although these leading stem cell centers have built a good reputation in regenerative medicine, it is still important to probe these clinics before the proper procedure. These questions should cover what to expect from the treatment, safety and emergencies, cost, and the patient’s rights.

Treatment

• What possible benefits can the patient get from stem cell therapy? How can these be measured and how long will it take?
• Are there other medications or special care the patient needs aside from the treatment?
• Which stem cell source best fits the patient’s condition?
• What are other treatment options for the patient’s condition?
• What is their stem cell procedure (from harvesting to follow-up check-up)?

Safety and Emergencies

• If the patient is given donor stem cells, what are the success and failure rates of the therapy?
• Are there possible long-term side effects of the treatment?
• In case a side effect develops, what do stem cell centers do, who will the patient reach out to, and how immediate can they respond to the side effect?
• How experienced are the doctor and the support staff who will perform the procedure?
• How advanced and sterilized is the clinic’s equipment?

Costs

• What are the expenses for stem cell therapy?
• What other costs will the patient incur?

Patient’s Rights

• What are the patient’s rights (confidentiality, update for new information, and the right to withdraw from the procedure)?

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Have you had a stem cell transplant? What stem cell clinic did you use? Share your answers in the comments below.

Footnotes
[1] Aabb.org. (2017). Cellular Therapies. [online] Available at: http://www.aabb.org/advocacy/regulatorygovernment/ct/Pages/default.aspx [Accessed 4 Aug. 2021].