3 New Level 1 Studies: PRP vs Bone Marrow Aspirate, ‘Stem Cells’
Elizabeth Hofheinz, M.P.H., M.Ed. • Wed, April 26th, 2017
There are three particularly interesting knee research projects underway at the Andrews Institute these days. Adam Anz, M.D., an orthopedic surgeon with the Andrews Institute for Orthopaedics & Sports Medicine, based in Gulf Breeze, Florida, is involved in each of the studies.
For one study, Dr. Anz is working with the primary investigator (PI), Joshua Hackel, M.D., on research funded with a grant from EmCyte Corporation, an autologous regenerative biologics company based in Fort Myers, Florida. This is a randomized, controlled clinical trial that compares the effectiveness of bone marrow aspirate concentrate (BMA) to platelet rich plasma (PRP) injections for the treatment of knee osteoarthritis (OA).
Dr. Anz, who leads the Andrews Research and Education Foundation’s Regenerative Medicine Center, told OTW, “This is an investigator initiated, industry-funded study comparing one injection of Leukocyte Poor PRP to one injection of bone marrow aspirate concentrate for knee arthritis. We are looking to determine how these two point of care biologic products perform in controlling the symptoms of knee joint degeneration.”
Then there is the study meant to help those who with knee OA who have found no relief to date. Dr. Anz, along with the PI, Brett Kindle, M.D. and co-authors Joshua Hackel, M.D., Michael Milligan, M.D., and Roger Ostrander, M.D., have undertaken a double-blind, multicenter, randomized, saline-controlled trial that will evaluate the efficacy of a single dose of autologous protein solution (APS) in patients with symptomatic knee OA who have not been able to get satisfactory pain relief with prior treatment.
Dr. Anz commented to OTW, “This is an industry-initiated, industry-funded study evaluating the safety and efficacy of a point of care blood product under development by Zimmer/Biomet to control the symptoms of knee joint degeneration. Basic Science studies of the product have illustrated an upregulation of anti-inflammatory proteins. We are one of a number of clinical sites involved.”
In another study, Dr. Anz teamed up with co-investigators Drs. Hackel and Ostrander for work sponsored by the Kuala Lumpur Sports Medicine Centre. They are evaluating articular cartilage regeneration in patients with chondral lesions treated by arthroscopic subchondral drilling followed by postoperative intra-articular injections of hyaluronic acid (HA) with and without peripheral blood stem cells (PBSC).
Dr. Anz told OTW, “This is an industry-initiated, industry-funded study evaluating the safety and efficacy of a cartilage regeneration technology involving autologous stem cells. This study is seven years in the making requiring us to build a GMP [good manufacturing practice] compliant tissue processing and storage facility to house the stem cells. The technology involves combining arthroscopic surgery with multiple postoperative stem cell injections, with a goal of regenerating cartilage. We have been collaborating with an orthopaedic surgeon in Kuala Lumpur, Malaysia, who has been performing the technique since 2007 with histology and randomized controlled trial data suggesting that the cartilage has good quality and is nearly normal.”