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3 Stem Cell Product Updates: Knee OA Clinical Trials, Degenerative Disc Treatment Launch

In the span of three weeks, three small companies focused on stem cells announced advancements in their commercialization processes. Clinical trials are underway for use of stem cell therapies in the treatment of knee osteoarthritis. Personalized Stem Cells is conducting clinical trials in the U.S., while Cellular Biomedicine is executing trials in China. On the spine side, Creative Medical Technology is commencing U.S. product commercialization for a regenerative stem cell procedure to treat chronic lower back pain.

Personalized Stem Cells (PSC), a California company, enrolled the first of up to 125 patients in its FDA-approved clinical trial for an autologous adipose-derived stem cell treatment for knee osteoarthritis (OA). Trial sites are located throughout the U.S., with additional sites to come in 4Q19 and early 2020. Future trials are planned for other orthopedic applications, including hips and shoulders.

PSC is working within FDA’s regulations to provide stem cell therapies that follow FDA’s guidelines, assuring consistent manufacturing, quality-tested cells and clinical trial/manufacturing oversight for safety and efficacy.

Cellular Biomedicine’s drug application for ReJoin therapy for knee OA has been accepted for a Phase II clinical trial in China. ReJoin is an off-the-shelf autologous mesenchymal progenitor cell therapy, developed completely in-house. It comprises adipose tissue obtained from the patient that is expanded using a serum- and antibiotics-free culture medium, which is then formulated for ReJoin.

This marks the company’s second clinical trial accepted in China for stem cells this year, following a trial of AlloJoin allogeneic therapy for the same application. Cellular Biomedicine is a clinical-phase biopharmaceutical firm based in New York.

Creative Medical Technology (CMT) plans to commence commercialization of StemSpine, a regenerative stem cell procedure for the treatment of degenerative disc disease, in the U.S. within 2019. The procedure has been employed successfully ex-U.S. with over 12 months of data showing safety and efficacy.

The patented procedure offers a drug-free alternative for the treatment of chronic lower back pain using a patient’s own stem cells. CMT’s technology uses biologic elements to stimulate development of new blood vessels and counteract deficient circulation that may contribute to disc degeneration. By increasing circulation, CMT expects to modify the disc environment to give injected stem cells optimal conditions for regeneration. This is the first orthopedic product for New York-based CMT.



Julie A. Vetalice is ORTHOWORLD’s Editorial Assistant.

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