Grove City

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating the safety and potential treatment effects of autologous cell therapy for pain and inflammation linked to Osteoarthritis of the hip. This prospective open-label Phase 2 study initially includes 50 patients, with plans to follow a larger group of 4,000 patients later. The study focuses on patients with hip osteoarthritis caused by degeneration or chronic injury. Participants will receive injections of autologous StroMed obtained via the Adipose Ultrasonic Cell Recovery Unit (AUCRU) and Platelet Rich Plasma (PRP) processed by the RegenLab (RegenKit BCT-3) directly into the affected hip joints. On Day 0, patients get both StroMed and PRP injections, followed by PRP injections alone on Days 7, 14, and 30. These treatments aim to address pain and inflammation in the affected hips. During the study, participants will have laboratory tests to monitor inflammation markers, complete Hip Osteoarthritis Outcome Score (HOOS) surveys at 0, 2, and 6 months, and undergo follow-up MRIs. Additional assessments include SF-36 quality of life forms and numerical rating scales to evaluate safety and treatment effects. Researchers will also track any reductions in medication use or delays in hip replacement surgery over the 6-month period.

Researchers are evaluating the safety and potential treatment effects of autologous cell therapy for pain and inflammation caused by osteoarthritis of the knee in this Phase 2 open-label clinical study. The initial study includes 50 patients, with a planned follow-up involving a larger group of 4,000 patients. Participants have knee osteoarthritis due to degeneration or chronic injury and experience pain lasting more than six months. Patients receive treatment using autologous StroMed obtained through a mechanical process without enzymes or drugs, preserving the natural cell structure. Platelet Rich Plasma (PRP) processed by the RegenLab RegenKit BCT-3 is also injected directly into the affected joint. Two treatment groups receive different PRP schedules: Cohort 1 receives PRP at baseline, 1 week, 2 weeks, and 1 month; Cohort 2 receives PRP at baseline, 1 month, and 2 months. Throughout the study, participants undergo MRI scans, laboratory tests for inflammation markers, and complete knee injury and osteoarthritis outcome score (KOOS) surveys at 0, 2, and 6 months. Quality of life is assessed using SF-36 forms and numerical rating scales. Researchers also monitor safety, medication use, and any delay in knee replacement surgery. The total study duration includes follow-up assessments up to six months after treatment.

Researchers are evaluating the safety and potential benefits of autologous cell therapy for pain and inflammation in patients with osteoarthritis of the shoulder. This prospective open-label clinical study initially involves 50 patients and will later include a larger group of 4,000 patients. The trial focuses on osteoarthritis caused by degeneration or chronic injury to the shoulder joint. Participants will receive treatment with autologous StroMed cells obtained through the Adipose Ultrasonic Cell Recovery Unit along with Platelet Rich Plasma (PRP) processed by the RegenLab RegenKit BCT-3. At the start (Day 0), patients get injections of both StroMed and PRP directly into the affected shoulder joint, followed by PRP injections alone on Days 7 and 14. During the 6-month study, patients will be monitored using laboratory tests for inflammation, MRI scans, and questionnaires including the DASH, SPADI, SF-36 quality of life survey, and numerical rating scales. Researchers will also track any changes in medication use or delays in planned shoulder surgery. The main outcome measured is change in the DASH survey at 0, 2, and 6 months to assess arm, shoulder, and hand function.