Grove City

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Researchers are evaluating autologous cell therapy to study its safety and potential to treat pain and inflammation associated with Osteoarthritis of the hip. This prospective open-label study initially includes 50 patients, with a larger follow-up group planned involving 4,000 patients. The condition involves degeneration or chronic injury affecting the hip joint. Patients will receive autologous StroMed cells obtained using the Adipose Ultrasonic Cell Recovery Unit and Platelet Rich Plasma PRP processed by the RegenLab RegenKit BCT-3. These will be injected directly into the affected hip joints. The treatment schedule includes an initial combined injection of StroMed and PRP on day 0, followed by PRP injections alone on days 7, 14, and 30. This approach uses a mechanical process without enzymes or drugs, aiming to minimize risks. Participants will be monitored through laboratory tests for inflammation markers, hip disability and osteoarthritis outcome score HOOS questionnaires, and follow-up MRIs up to 6 months. Additional assessments include SF-36 quality of life surveys and numerical rating scales for pain. Researchers will also observe any changes in medication use or delays in hip replacement surgery. The study measures changes in HOOS scores primarily at 0, 2, and 6 months.

Researchers are evaluating the safety and potential treatment effects of autologous cell therapy for pain and inflammation caused by osteoarthritis of the knee. This prospective open-label clinical trial initially includes 50 patients, with plans for a larger follow-up study involving 4,000 participants. The trial focuses on patients suffering from knee osteoarthritis due to degeneration or chronic injury. Participants will receive autologous Stromed cells obtained through a mechanical process without enzymes or drugs, combined with Platelet Rich Plasma PRP processed by RegenLab. The treatment involves direct injections into the affected knee joints. Patients are divided into two groups Cohort 1 receives PRP injections at the time of initial StroMed treatment and then at 1 week, 2 weeks, and 1 month Cohort 2 receives PRP at the initial treatment and then at 1 month and 2 months. During the study, patient outcomes will be monitored through MRI scans at various points up to 6 months, blood tests for inflammation markers, and questionnaires including the Knee Osteoarthritis Outcome Score KOOS, the SF-36 quality of life survey, and numerical rating scales for pain. Researchers will also observe any reduction in medication use or delay in knee replacement surgery. The trial runs from July 2015 to August 2026 and includes regular follow-ups to assess safety and effectiveness.

Researchers are evaluating autologous cell therapy as a potential treatment for pain and inflammation caused by Osteoarthritis of the shoulder. This open-label study aims to assess the safety and treatment potential of this approach in 50 patients, with plans for a larger follow-up study involving 4,000 patients. The study is sponsored by VivaTech International, Inc. and focuses on patients with shoulder osteoarthritis due to degeneration or chronic injury. Participants will receive autologous StroMed cells obtained using the Adipose Ultrasonic Cell Recovery Unit and Platelet Rich Plasma PRP processed by the RegenLab RegenKit BCT-3. These treatments are given as direct injections into the affected shoulder joints, with an initial combined injection of StroMed and PRP on day 0, followed by PRP injections on days 7 and 14. The StroMed cells are mechanically processed without enzymes or drugs, maintaining the extracellular matrix and minimizing risk to patients. Throughout the study, participants will undergo laboratory tests to track inflammation markers and complete several questionnaires including the DASH, SPADI, SF-36 quality of life, and Numerical Rating Scale for pain at 0, 2, and 6 months. MRI scans of the affected joint will be performed at baseline and optionally at 6 months to assess changes. Researchers will monitor safety, treatment effects, medication use, and any delay in shoulder replacement plans over a six-month period.