Stem Cell Clinics: Regulations, Protocols, and Cell Products

Is stem cell therapy FDA approved?

Currently, the FDA has not authorized the use of culturally expanded cells within the United States - meaning patients must look elsewhere for this new exciting area of medicine.  This poses challenges, as many clinics operate strictly for profit - leading to a decline in cell quality, protocol standardization, and in the worst case jeopardizing patient safety and treatment efficacy.  It is important now more than ever, for patients to comprehensively research different facilities and protocols to encourage the best chances of a successful and safe treatment experience.

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What is DVC Stem?

DVC Stem is a facility conducting an ongoing phase II/III patient-funded clinical study named The Effects of Cord Tissue Derived MSCs on the Treatment of Chronic Low-Grade Inflammation.

DVC Stem's IRB-approved protocol consists of a two-day period that involves the intravenous (IV) transplant of 300 million culturally expanded human umbilical cord tissue-derived adult mesenchymal stem cells (MSCs). The cells are administered manually at ~1cc per minute by the Medical Director, Louis A. Cona, MD. 

Their study is registered with the Cayman Islands Government (Trial HPC/CTR/003) and thus the clinic and Medical Director must adhere to strict regulations concerning cell quality, protocol consistency, and patient safety. 

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What is a phase II/III clinical study?

A study that tests how well a new treatment works for a certain condition and compares the new treatment with standard treatment. Phase II/III clinical trials may also provide more information about the safety and side effects of the new treatment. Combining phases II and III may allow research questions to be answered more quickly or with fewer patients. 

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Why is IRB-approval important?

DVC Stem's treatment protocol has been approved by an Institutional Review Board (IRB) in California, United States. The IRB reviews the protocol set forth by Medical Director, Louis A. Cona MD annually to ensure patient safety and treatment efficacy.

Under FDA regulations, an Institutional Review Board is a group that has been formally designated to review and monitor biomedical research involving human subjects. Following FDA regulations, an IRB has the authority to approve, require modifications (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.

This certification is designed to optimize the chances of treatment efficacy and ensure patient safety. The goal of the study is to collect safety and efficacy data related to the intravenous administration of culturally expanded mesenchymal stem cells.

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Why use mesenchymal stem cells in a clinical setting?

Many peer-reviewed studies have showcased mesenchymal stem cells (MSCs) self-renewal, differentiation, anti-inflammatory, and immunomodulatory properties which may play a role in reducing levels of inflammation throughout the body – the primary study endpoint of DVC's study. 

In-vitro (performed in a laboratory setting) and in-vivo (taking place in a living organism) studies have also supported the understanding of mechanisms, safety, and efficacy of MSC therapy in clinical applications. (1)

The anti-inflammatory properties of mesenchymal stem cells (MSCs) play a key role in their therapeutic abilities.  This attribute of MSCs also means multiple inflammatory-based conditions may be positively impacted by a large infusion of mesenchymal stem cells.

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What is inflammation?

Inflammation is a response from the immune system that is aimed at protecting the body from harmful external stimuli as well as aiding and repairing the body. However, when dysregulated inflammation can have a detrimental effect on the body. An immune system that is dysregulated for an extended period can lead to a variety of autoimmune conditions such as Multiple Sclerosis, Type 1 Diabetes, Inflammatory Bowel Disease, or Lupus. (8)

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How mesenchymal stem cells (MSCs) reduce inflammation

"MSCs from different sources reduce inflammation by decreasing production of tumor necrosis factor-α (TNF-α) and Interferon-γ (IFN-γ) and increasing Prostaglandin (PGE2) and Interleukin-6 (IL-6) secretion." (2)

According to a 2020 study conducted by Gugjoo et al. 

"In general, the central role of mesenchymal stem cells (MSCs) in maintaining homeostasis (immuno-modulation and anti-inflammatory activities) occurs by interacting with immune cells and is mediated through cytokines, chemokines, cell surface molecules, and metabolic pathways. MSCs suppress T-cell proliferation, cytokine secretion, and cytotoxicity (9)"

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How does DVC Stem differ from other stem cell clinics?

1) The treatment protocol involves the systemic administration of a culturally expanded mesenchymal stem cell product - which is not authorized in the United States.   The dosage is standardized to 300 million mesenchymal stem cells per patient split into 6 separate vials of 50 million cells to ensure smooth administration and prevent any cell clumping.

2) The facility is required to submit efficacy data every year to its IRB to continue enrolling patients. The clinic is directly regulated by the Cayman Islands Government, which has strict criteria that must be followed to conduct patient-funded clinical trials.

3) Rather than making direct claims to be able to treat specific conditions – rather the team utilizes information on the website as statistical tools using data collected from third-party peer-reviewed studies. DVC aims to help shed light on an area of medicine that is often overlooked or misunderstood.

4) DVC Stem's cell product and treatment protocols are highly regulated and patient safety is of utmost importance. The mesenchymal stem cells are ethically sourced from AATB certified, US-donated, full-term human umbilical cords and processed in our award-winning partner medical laboratory located in the USA, which is fully FDA registered, cGMP compliant, ISO 9001, and ISO 13485 certified. 

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The cells are tested to ISCT standards for viability to ensure they meet minimum QA requirements multiple times before treatment. To ensure cell safety, we conduct advanced therapy testing for sterility, endotoxins, mycoplasma, HIV-1/HIV-2, Hepatitis B, Hepatitis C, and Syphilis on the cells post expansion as well as the donated umbilical cords.

Confirmation of identity (URMC Flow Cytometry) testing is also conducted to ensure post-thaw viability, and MSC phenotype expression (CD73+, CD90+, CD105, etc.). This ensures a standardized cell product which helps the medical team provide further insight into treatment efficacy

5) DVC Stem is transparent with any inquiries concerning treatment protocols, efficacy data, and cell products, the facility and staff never aim to mislead anyone or make false claims on the website that cannot be backed up with real data.

6) DVC Stem's treatment protocol is designed in such a way as to ensure patient safety – this would not be possible if there were not hundreds of peer-reviewed studies that came before ours that showcased the safety of mesenchymal stem cells derived from umbilical cord tissue when used in a clinical setting.
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There is a plethora of research surrounding the mechanisms of mesenchymal stem cells (MSCs).

Many studies have outlined their diversified capabilities including self-renewal, immunomodulatory, anti-inflammatory, signaling, and differentiation properties. These characteristics enable MSCs to be used in a variety of clinical settings for multiple degenerative conditions.  DVC Stem provides an expanded stem cell treatment that utilizes umbilical cord tissue-derived mesenchymal stem cells (UC-MSCs) sourced from an FDA-compliant lab in the United States. DVC Stem offers stem cell therapy for a variety of conditions including Multiple Sclerosis, Crohn's Disease, Parkinson's, and other autoimmune conditions. If you have any questions related to DVC Stem's treatment protocol, cell product or facility please visit the FAQ Page.

References: 

(1) Chu, D.-T., Phuong, T. N. T., Tien, N. L. B., Tran, D. K., Thanh, V. V., Quang, T. L., … Kushekhar, K. (2020, January 21). An Update on the Progress of Isolation, Culture, Storage, and Clinical Application of Human Bone Marrow Mesenchymal Stem/Stromal Cells. International journal of molecular sciences. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7037097/.

(2) Gugjoo, M. B., Hussain, S., Amarpal, Shah, R. A., & Dhama, K. (2020). Mesenchymal Stem Cell-Mediated Immuno-Modulatory and Anti- Inflammatory Mechanisms in Immune and Allergic Disorders. Recent patents on inflammation & allergy drug discovery. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7509741/.