Microfracture vs ADSC for Knee Cartilage Repair
Trial Summary
What is the purpose of this trial?
The purpose of this study is to compare two biologic methods for the treatment of articular cartilage defects in the knee. The first method, microfracture, is the standard of care and is routinely used to recruit cells from the subchondral bone marrow to the site of cartilage loss. The second method is the application of adipose-derived stem cells (ADSCs) to the defect site. In theory, ADSCs on a collagen scaffold should enable the delivery of more specific progenitor cells to the site of injury, resulting in better regeneration and integration of articular cartilage at the site of a defect as compared to the microfracture method.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.
What data supports the effectiveness of this treatment for knee cartilage repair?
Research shows that using adipose-derived stem cells (ADSCs) combined with platelet-rich plasma (PRP) leads to better cartilage repair compared to microfracture surgery alone in animal models. Additionally, ADSCs have been shown to improve cartilage healing in full-thickness defects, suggesting their potential effectiveness in knee cartilage repair.12345
Is adipose-derived stem cell therapy safe for knee cartilage repair?
Adipose-derived stem cell therapy for knee osteoarthritis has been shown to be generally safe in humans, with studies reporting minimal complications such as temporary knee pain and swelling. No serious adverse events were reported in trials, indicating a low risk associated with this treatment.34678
How does the treatment for knee cartilage repair using microfracture and ADSC differ from other treatments?
The treatment using adipose-derived stem cells (ADSCs) combined with platelet-rich plasma (PRP) offers a novel approach by enhancing cartilage repair quality compared to traditional microfracture surgery. This method involves injecting ADSCs directly into the joint, which may lead to better cartilage defect filling and improved outcomes.12349
Research Team
Seth Sherman, MD
Principal Investigator
Stanford University
Jason Dragoo, MD
Principal Investigator
University of Colorado, Denver
Eligibility Criteria
This trial is for individuals aged 18-50 with a specific knee cartilage defect less than 400mm^2 on the femoral condyle and neutral leg alignment. It's not for those over 50 or under 18, with a BMI over 30, advanced osteoarthritis, or previous knee cartilage procedures.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo an arthroscopic surgical procedure, either ADSC application or microfracture, followed by physical therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment, with outcome questionnaires and MRI scans at 6, 12, and 24 months post-operatively
Treatment Details
Interventions
- ADSC Application
- Microfracture
ADSC Application is already approved in United States, European Union for the following indications:
- Knee osteoarthritis
- Articular cartilage defects
- Orthopedic conditions
- Regenerative medicine applications
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
Stanford University
Collaborator
University of Kentucky
Collaborator