Cooper is stepping into the forefront of clinical translational medicine with a multi-disciplinary, evidence-based, bench-to-bedside approach to stem cell research.
“There’s a lot of hype that stem cells are the miracle cure that will do everything,” says Spencer A. Brown, PhD, Cooper’s director of surgical research. “But too many of these claims aren’t based on strict scientific inquiry. We aim to separate the hype from the hope in this field with step-by-step studies that break new ground to prove the safety and efficacy of stem cells in treating a range of diseases.”
Patient enrollment is now underway for the first such study at Cooper, an FDA-approved IDE (investigation device exemption) trial to test the safety and efficacy of autologous adipose-derived stromal vascular fraction (SVF) cells in treating osteoarthritis (OA) of the knee. The study will collect and disassociate adipose tissue and inject the SVF into the knee of the same patient. The study is controlled, randomized, and double-blinded with two SVF treatments (high- and low-dose) and a placebo control. This study is multi-disciplinary with Lawrence S. Miller, MD (PI) from Orthopaedics and Steven C. Bonawitz, MD and Martha S. Matthews, MD from Plastic Surgery.
“We are one of only three sites in the nation participating in this trial, which is the first of its kind in human subjects,” Dr. Brown notes. “We’re hopeful this pivotal study will answer questions about how many cells are needed and whether there is an age, gender or severity of disease in which this treatment won’t work. If successful, the treatment can be marketed commercially and expanded to OA of other joints.”
Cooper is also looking to expand into or develop other trials that will study the application of stem cells in treating such conditions as septic shock in the Trauma bay and erectile dysfunction.
“We are already involved in a large animal phase looking at diabetic wound healing involving stem cells,” he says. “The promise in wound healing is very good because stem cell treatment increases the vasculature of wounds.”
In addition, Cooper is the recipient of a three-year, $2.2 million award to study a newly identified mesenchymal stem cell (MSC) and its role in cancer, wound healing, and vision issues. MSCs are stromal cells that can differentiate into a variety of cell types, including osteoblasts ( bone cells), chondrocytes (cartilage cells), myocytes (muscle cells), and adipocytes (fat cells that give rise to marrow adipose tissue).
“These funds were given by a grateful patient whose life was saved by Richard D. Lackman, MD (chief of orthopaedic oncology at the MD Anderson Cancer Center at Cooper), a leader in sarcoma research and treatment,” Dr. Brown says. “Our efforts are building on the scientific work of Mindy George-Weinstein, PhD, Chief Research and Science Officer at Philadelphia College of Osteopathic Medicine. The Cooper Surgery Department Laboratory now includes five PhDs, a research manager, and a full-time research writer.
“We are very excited about the possibilities of stem cell research and the clinical benefits it promises,” he continues. “Our hope is to become a center of excellence in this area by following FDA-approved pathways to prove these treatments work, training others in their application, working with companies to bring medications to market, and offering groundbreaking therapeutic options to patients.”
If you have a patient who may be a candidate for enrollment in the pivotal study testing autologous adipose-derived SVF cells in treating knee osteoarthritis, please contact Dr. Brown at Brown-Spencer@cooperhealth.edu.