Golden, Colorado—March 12, 2019—Vitro Diagnostics, Inc. (OTCPK: VODG), dba Vitro Biopharma announced receipt of provisional approval from the National Stem Cell Ethics Committee (NSCEC) of the Ministry of Health of the Commonwealth of the Bahamas for a clinical trial entitled “Vitro Biopharma Allogeneic Mesenchymal Stem Cell Therapy for Musculoskeletal Conditions”.
This broadens Vitro Biopharma’s expansion into highly regulated stem cell trials in collaboration with the Nassau-based Medical Pavilion of the Bahamas (TMPB). http://www.tmp-bahamas.com
Vitro Biopharma currently provides numerous products to support cancer and stem cell research that were originally introduced into commercial distribution in 2008. While our research products gained significant commercial recognition, we also expanded into clinical markets for our highly competitive stem cell culture media, MSC-Gro™. This resulted in the use of MSC-Gro™ in an extensive osteoarthritis (OA) clinical trial in Australia. MSC-Gro™ was used to expand adipose-derived Mesenchymal Stem Cells (“MSCs”) prior to injection into arthritic knees, shoulders and hips. These results provided evidence of safety and efficacy in over 600 patients including pain reduction, functional improvement, reduced need for joint replacement and cartilage regeneration. These results have been duplicated and extended in 35 published clinical trial results from 2385 patients. Pre-clinical studies in over 20,000 animals also support clinical safety and efficacy of MSC transplants for OA.
The new trial in the Bahamas licenses Vitro Biopharma to use its AlloRx Stem Cell™ product to treat OA, ligament and tendon injury, meniscus reduction/injury, and herniated disc. Prior therapies relied predominantly on stem cells derived from the same patient known as an autologous stem cell transplant. Vitro Biopharma’s trial in the Bahamas will test the safety and efficacy of our donor-derived allogenic AlloRx Stem Cell™ product. This trial will provide important clinical data to be utilized in gaining future FDA approvals for use in the US market. A similar allogeneic stem cell product has been recently approved in the EU for treatment of a type of Crohn’s disease.
Dr Jim Musick, CEO/CSO of Vitro Biopharma said, “We are very pleased by the recognition by the NSCEC of the Bahamas and respect their rigorous oversight of stem cell research. We are completing the specified steps needed to enroll patients and will provide updates as we progress. This trial will compliment and extend ongoing clinical trials in the Cayman Islands through our partner DVC Stem www.DVCStem.com for inflammatory conditions such as multiple sclerosis and trials in New Zealand for neurodegenerative diseases.
We will now be able to extend stem cell therapy based on our novel, patent-pending AlloRx Stem Cell™ product to a variety of musculoskeletal conditions. These include OA of any joint, ACL/MCL tear, Achilles tendon rupture, rotator cuff injury and tennis elbow that are highly prevalent and have few disease-modifying options. It is important to note that many stem cell therapies now performed are problematic due to limited potency and failure to meet basic criteria of stem cells. Also, contamination due to use of illegitimate production methods that are not in compliance with FDA regulations can cause serious complications. Vitro Biopharma has operated a highly regulated, FDA-compliant commercial biologics manufacturing operation for several years and is cGMP compliant, ISO 9001 Certified, FDA/CLIA registered and ISO 13485 compliant. All manufacturing occurs in a certified sterile clean room with extensive and advanced testing to assure the absence of contamination. Furthermore, in numerous patients treated to date by IV infusion of AlloRx Stem Cells™ there have been no significant adverse events.”
We have partnered with Dr. Conville Brown, MD, MBBS, FACC, FESC, PhD, the founder and CEO of the Medical Pavillion of the Bahamas who is the Principal Investigator of this trial and director of its clinical administration. Dr Brown was instrumental in the establishment of the NSCEC in the Bahamas. Dr. In Sok Yi, MD a respected Denver, Colorado orthopedic surgeon with a specialty in hand surgery is a medical consultant on the Vitro Biopharma Clinical Team.
Dr. Conville S Brown said, “I am very pleased to be working with Dr. Musick and his team at Vitro Biopharma on this new clinical trial. We look forward to being able to provide regenerative medicine therapeutic options for musculoskeletal conditions.”
About the Medical Pavilion of the Bahamas: TMPB operates within a 40,000 square foot building as a partnered care specialty medical facility with 10 different centers in various areas including cardiology, cancer, clinical research and kidney disease. One of the centers is the Partners Stem Cell Centre, where the present trial will be conducted. The Partners Stem Cell Centre provides an environment to conduct stem cell research and clinical trials under the model of “FDA rigor in a Non-FDA Jurisdiction” TMPB employs 20 medical specialists in various fields. See www.tmp-bahamas.com for additional information.
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Dr. James Musick
Chief Executive Officer
(303) 999-2130 Ext. 3
Source: Vitro Diagnostics, Inc.