Regenexx is currently seeking candidates for a knee osteoarthritis study that is taking place in Chicago, Illinois. Additional information is provided below. Complete details on the study can be found at the clinicaltrials.gov website.
Regenexx-SD Stem Cell Procedure Overview
Stem cells are in all of us and they act as the repairmen of the body. However, as we age and our joints experience damage from acute injuries or arthritis, we sometimes can’t get enough of these critical repair cells to the injured area. The Regenexx Procedures help solve this problem by amplifying the body’s natural repair process. This is accomplished by harvesting cells from areas known to be rich in mesenchymal stem cells and then concentrating those cells in a lab before precisely reinjecting them into the damaged area in need of repair.
For a more complete overview of the procedure. Visit the Regenexx-SD page
Detailed Explanation of this Study
The study is a single center, prospective, randomized, controlled trial to include 50 subjects, 25 treated with Regenexx-SD and 25 treated with Exercise Therapy for treatment of knee osteoarthritis. Subjects will be enrolled within 60 days prior to Regenexx-SD injection or initiation of Exercise Therapy and take part in follow-up visits for two years following treatment. A preoperative visit will occur at the time of enrollment; follow-up visits will occur at the clinical site at 6 weeks, 3 months, 6 months, 12 months, and 24 months post injection.
Subjects in the control, exercise therapy arm, will have the opportunity to cross-over to the study treatment arm at or after the 3 month visit if they do not respond to the exercise therapy. They will continue to be followed through 24 months.
Subjects will complete the study following the 2 year follow-up visit. They will be withdrawn from the study prematurely if a revision occurs.
The study subjects will be compared to a historical total knee arthroplasty group. Data of the TKA group subjects will be reviewed retrospectively after it is retrieved from the clinical database. The TKA group will consist of patients who underwent TKA for knee osteoarthritis. The inclusion criteria of age and BMI will be applied to these subjects.
About Dr. Mitchell Sheinkop
Dr. Sheinkop is a Board-Certified Orthopedic Surgeon, former director of the joint replacement program and Professor Emeritus at Rush University Medical Center.
He is a leading authority on the treatment of patients with complex hip and knee disorders, and is well known for his pioneering use of computer-assisted navigation, minimally-invasive technologies and hip resurfacing techniques. Dr. Sheinkop is a graduate of the Chicago Medical School and did fellowships in pediatric orthopedics and hand surgery. He has done extensive research in the fields of uni-compartmental, minimally invasive solutions, hip resurfacing systems, and navigated arthroplasty.
Call Regenexx at 312-957-8282 for a pre-screening discussion if you meet the requirements below and are interested in taking part in this study.
Knee Osteoarthritis Study Patient Requirements
- The patient must be willing to come to the Chicago, IL clinic for first an initial evaluation to make a final determination of study eligibility. If eligible, the patient must be willing to return for treatment at the Chicago, IL clinic and for all post-injection evaluations (6 weeks, 3 months, 6 months, 12 months, 24 months)
- There is no guarantee a candidate will be eligible
- The cost of this evaluation and the follow-up clinic visits will be billed to the patient and/or their insurance
- Costs of any travel will be the responsibility of the patient
- The patient will be randomized to receive either Regenexx-SD treatment or be instructed in a home exercise therapy program
- Patients in the exercise therapy group will have the opportunity to receive a Regenexx SD treatment after the three month visit if they do not respond to the exercise therapy
- The Regenexx SD treatment will be provided at no cost to the patient
- The patient must have a set of knee x-rays current within the last year at their own cost for study screening purposes.
- The subject must meet all inclusion criteria and not meet any exclusion criteria (complete list below). Key criteria include:
- Age 18-70
- Can comply with all post-operative evaluations and visits
- Diagnosis of knee osteoarthritis
- No knee surgery within the last 6 months
- No immunosuppressive or chemotherapy in the last five years
Inclusion Criteria for This Trial
Candidates must meet ALL of the following:
- Voluntary signature of the IRB approved Informed Consent
- Ages 18 to 70
- Diagnosis of Knee osteoarthritis
- Kellgren-Lawrence Grade 2 or 3 on X-Ray
- BMI of <30
- Minimum flexion to 110 degrees
- Varus under 12 degrees/Valgus under 15 degrees
- Instability in any plane less than 2 mm translation
- ACL intact and no history of ACL reconstruction
- Knee Society 100 point score > 65
- If bilateral arthritis, subject must be able and willing to delay treatment of the second side for at least 6 months
- Candidate is able to follow Regenexx medication guidelines
- Patient agrees to return for periodic assessment protocol
- Patient must execute all required documents
- Patient must be appraised of Clinical Trial
Exclusion Criteria for This Trial
Candidates will be excluded if they meet ANY of the following:
- History of infection of the joint in the last five years
- Intra-articular PRP, steroid or viscosupplementation in the last three months
- Previous knee surgery within the last 6 months
- Flexion contracture over 15 degrees
- Low back pain with radiculopathy or with “significant” radiographic changes
- History of immunosuppressive or chemotherapy in the last five years
- Systemic neurological disease
- HIV positive or chronic hepatitis
- Any significant co-morbidity that in the opinion of the investigator should exclude the subject from the study