Clinical Trial Support
Dedicated to Evidence-Based Research
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Gulf Coast Biologics (GCB) clinical trial activities are dedicated to the development of evidence-based advanced treatment and technologies in regenerative medicine. This includes identifying the clinical protocols needed to safely and effectively treat patients with regenerative biologics. Our professional reach includes access to renowned and experienced physicians who are thought leaders and experts in their field of practice. GCB collaborates with EmCyte Corporation, Konical Minolta, Biosciences Research & Associates, Inc., and others to provide support for clinical trials. Our collaborators provide equipment, product and data analysis services at heavily discounted prices to physicians looking to conduct clinical trials through GCB. In addition to this support, GCB offer technical review and analysis of study outlines by its core staff of key opinion leaders.
Supported Clinical Trial Studies
ASPIRE™ Bone Marrow Aspirate and Concentration in Knee Osteoarthritis
Dr. Ken Mautner MD is the principal investigator of this study that aims to clarify whether aspiration of MSCs from bilateral PSIS is better than only aspirating from one side (i.e. unilateral PSIS), as demonstrated by the MSC counts obtained in each scenario. We also intend to use patient VAS scores to further clarify best practices. Finally, we intend to measure patient outcomes in a longitudinal fashion (one month, 2 months, 6 months, and one year) and to correlate the outcomes to MSC counts.
PurePRP® vs. Bone Marrow Concentrate and Placebo in Chronic Lower Back Disorders
Dr. Annu Navani heads a multicenter RCT, in which chronic low back or leg pain in patients with internal disc disruption (IDD) is studied. The intervention to be studied is the intra-discal delivery of autologous PurePRP® or PureBMC® into the nucleus pulposus of the disrupted disc(s). In control patients saline will be injected. The research specific aims are whether there will be improvement in (a) pain and (b) function with the use of intra-discal PRP or BMC compared to control patients. Furthermore, safety and efficacy will be addressed. Moreover, the study is intended to provide information on disc morphological changes with the use of both PurePRP® and PureBMC®. The follow up period is conducted by an independent observer at intervals of 1 month, 3 months, 6 months, and 1 year.
Multicenter RCT for Treatment of Single Level and Multilevel Lumbar-Thoracic-Cervical Discogenic Pain, Treated with PurePRP®
This study is led by Dr. Sheldon Jordan, and is set up as a Multi-Center, Randomized, Controlled, Double-blind Study Evaluating the Safety and Efficacy of a PRP Autograft for Treatment of Single-Level and Multi-Level Lumbar, Thoracic, and Cervical Discogenic Pain, compared to control injections. Patients have pain for at least 3 months. In each spinal region 60 patients will be included, and treated with PurePRP®. Follow up is performed by and independent and blinded evaluator at 4 weeks, 8 weeks, and 26 weeks.
The use of PRP in Pre ACL Reconstruction
Dr. Eric J. Strauss, is currently contacting a study with the purpose to assess the ability of PurePRP®, leukocyte-poor, platelet rich plasma (PRP) treatment to reduce the level of pro-inflammatory synovial fluid biomarkers following an acute anterior cruciate ligament (ACL) tear.
Pilot Study Addressing the Differences in Cell Counts and Hemolysis Using Different Bone Marrow Aspiration Systems
Dr. Rowan Paul will conduct a pilot study were the aim is to clarify whether only aspiration of MSCs with the Marrow Cellution technique from the posterior superior iliac spine (PSIS) is better than aspirating with the Aspire BMA system and the subsequent processing and concentrating MSC’s with the PureBMC system, as demonstrated by laboratory analysis performed at an independent laboratory. The comparison will be executed in the same patient, with emphasis on cell counts and red cell hemolytic factors .
A comparison between PurePRP®, HA, and corticosteroids in knee OA
Dr. Richard Chang is getting IRB approval for this comparative study. The goal of this study is to determine the efficacy of ultrasound guided intra-articular knee injections of leukocyte reduced platelet rich plasma, high molecular weight hyaluronic acid, or corticosteroid in the treatment of unilateral mild to moderate knee osteoarthritis (OA). Although there are numerous studies comparing platelet rich plasma to hyaluronic acid for this condition, there is heterogeneity in the frequency, preparation, and type of PRP or HA that is used; none to date has included a corticosteroid treatment group in comparison to these two treatment options.