Next Generation Regenerative Medicine LLC
The study is a multicentered, randomized, double-blinded, placebo-controlled study conducted on the unilateral knee of 120 patients. The study compares the effectiveness of an injection of a mesenchymal stem cell preparation from autologous bone marrow aspirate (BMA) to a corticosteroid control for knee osteoarthritis. WOMAC, VAS pain scores, and MRI will be used for assessment. The study will be conducted at 3 sites in the United States.
Osteoarthritis, Knee
Bone Marrow Derived MSCs
Corticosteroid
Bone Marrow Aspirate
PHASE1
PHASE2
Osteoarthritis (OA) is the most common form of arthritis in the knee that affects millions of adults throughout the world and is the leading cause of disability. It is a degenerative type of arthritis that occurs most often in patients, as the cartilage in the knee joint gradually wears away. As the cartilage wears away, it becomes frayed and rough, and the protective space between the bones decreases. This can result in bone rubbing on bone and produce painful bone spurs. The patient experiences pain that worsens over time. Although current surgical therapeutic procedures to cartilage repair are clinically useful, they cannot restore a normal articular surface, and in many cases, resulted in the growth of inferior quality fibrocartilage. Therefore, techniques and practices have been developed to collect minimally manipulated bone marrow aspirate (BMA), that contains Bone Marrow Derived Mesenchymal Stem Cells (BMDMSCs) and other endogenous acellular components, from knee OA patients for autologous transplantation in the treatment of their knee OA. Participants will be randomized to study arms to receive a BMA injection to the intra-articular knee, subchondral knee, both intra-articular and subchondral knee, or to receive a corticosteroid injection to the knee. A corticosteroid injection is currently the standard of care for osteoarthritis patients having knee pain. All participants will undergo a procedure. Participants will be blinded as to whether they receive a BMA injection or a corticosteroid injection.
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 120 participants |
Masking : | DOUBLE |
Masking Description : | Corticosteroid as control both participant and investigator blinded. |
Primary Purpose : | TREATMENT |
Official Title : | A Study to Evaluate the Safety, and Efficacy of Minimally Manipulated Autologous Bone Marrow Aspirate to Treat Knee Osteoarthritis in Patients |
Actual Study Start Date : | 2022-08 |
Estimated Primary Completion Date : | 2024-06 |
Estimated Study Completion Date : | 2024-12 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years to 80 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Bluetail Medical Group
Chesterfield, Missouri, United States, 63005
Not yet recruiting
Scarpone Sports Regenerative
Steubenville, Ohio, United States, 43952
Not yet recruiting
Albano Clinic
Salt Lake City, Utah, United States, 84121