Outcomes Data of Bone Marrow Stem Cells to Treat Hip and Knee Osteoarthritis
The purpose of this study is to determine if Bone Marrow Concentrate may be successful in the treatment of osteoarthritis. Bone Marrow Concentrate is known to contain a community of cells that has been shown to have “regenerative” properties. This study is designed to evaluate the short-term clinical and x-ray outcomes of injections for hip and knee osteoarthritis. The study groups here included hip osteoarthritis where the intervention included a procedural, bone marrow concentrate injection, and knee osteoarthritis, which also contains the intervention including a procedural, bone marrow concentrate injection. The study population here included the orthopedic clinic, those with a diagnosis of hip or knee osteoarthritis, scheduled for an Autologous Bone Marrow injection.
This study has been completed but no results have been posted.
A Disease-based Treatment Study for Diagnosed Osteoarthritis Utilizing Adipose-derived Regenerative Cells
Subjects who have signed informed consent and Health Insurance Portability and Accountability Act (HIPPA) authorization, and are determined to meet all inclusion criteria and no exclusion criteria will be enrolled in this study and receive the ADRC treatment. The subject will have an injection procedure (ADRC treatment). For this study, a licensed physician trained in liposuction must perform the syringe liposuction procedure. The licensed physician who performs the lipoplasty may be the Investigator or a Non-Investigator Physician who is trained on the study protocol. All subjects will undergo a minor syringe liposuction procedure to acquire approximately 100 mL of lipoaspirate for preparation of ADRC using the Transpose RT System. The removed tissue is processed to extract a cell suspension (the cell product). Once the cell product has been obtained, tested, and found to conform to release criteria, the subject will be treated with the ADRC’s.
The focus of this study is to investigate the therapeutic benefit of autologous ADRC’s in patients with OA in various joints. The endure study allows subjects at Sanford Health and in the United States access to adipose-derived regenerative cells while reviewing safety for subjects with knee, shoulder, hip, ankle and wrist OA, using a more pragmatic and standard clinical approach.
This study has not started recruiting, so no results are posted.
Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Hip
This is a prospective open-label clinical study of 50 patients to determine safety and treatment potential of autologous cell therapy for pain and inflammation associated with Osteoarthritis of the hip. Follow-up will consist of a larger sample including 4,000 patients. Patients will be treated for Osteoarthritis (OA) of the hip due to degeneration or chronic injury. They will be treated with autologous Stromed obtained by the Adipose Ultrasonic Cell Recovery Unit (AUCRU) and Platelet Rich Plasma (PRP) processed by the RegenLab (RegenKit BCT-3) PRP product each as direct injections to the affected joints. Patient outcomes will be tracked with laboratory tests for inflammation markers, hip disability and osteoarthritis outcome score (HOOS) questionnaires and follow up MRI’s at various endpoints to 6 months. SF-36 forms (a quality of life measure) and numerical rating scales (NRS) will also be used to assess safety and efficacy of treatment, as well as any reduction in patient medication and/or delay in pending hip replacement therapy.
As for the intervention, patients will be treated with autologous StroMed obtained by the Adipose Ultrasonic Cell Recovery Unit (AUCRU) and Platelet Rich Plasma (PRP) processed by the RegenLab (RegenKit BCT-3) PRP product each as direct injections to the affected joints at the time of initial treatment. Thereafter the affected joints will be treated with direct injections to the joint with Platelet Rich Plasma processed by RegenLab (RegenKit BCT-3) PRP product. Day 0 [StroMed + platelet rich plasma (PRP)], Day 7, 14 and 30 [PRP]
For the study arms, because no enzymes or drugs are added with this mechanical process, the resulting (StroMed) cell concentrate still contains the extra-cellular matrix. In addition, the cells have not been altered by manipulation with enzymes or culturing. This autologous, cell concentrate is of minimal risk to the patient with no artificial ingredients added. Additional treatments with Platelet Rich Plasma (PRP) may be processed by the RegenLab (RegenKit BCT-3) PRP product by direct injection to affected joints.
This study is in active recruitment, so no results have been posted yet.