Using stem cells to treat knee osteoarthritis
The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis: A Randomized Controlled Trial
NA · University of Colorado, Denver · NCT03014401
This study tests if adding stem cell treatment to standard knee surgery helps people with mild to moderate osteoarthritis feel better and recover faster.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 29 (estimated) |
| Ages | 35 Years to 70 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver (other) |
| Locations | 3 sites (Santa Monica, California and 2 other locations) |
| Trial ID | NCT03014401 on ClinicalTrials.gov |
What this trial studies
This study compares the outcomes of patients with mild to moderate knee osteoarthritis who receive adipose-derived stem cell (ADSC) transplantation alongside standard arthroscopic treatment versus those who receive standard treatment alone. The aim is to evaluate whether the addition of ADSCs can enhance clinical and functional outcomes over a one and two-year follow-up period. The study focuses on patients undergoing procedures such as meniscectomy and cartilage stabilization, with the hypothesis that ADSCs may promote tissue repair and reduce inflammation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 35 to 70 with mild to moderate knee osteoarthritis who have not responded adequately to conservative treatments.
Not a fit: Patients younger than 35 or older than 70, or those with severe osteoarthritis, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved pain relief and functional recovery for patients suffering from knee osteoarthritis.
How similar studies have performed: Early studies have shown promising results with ADSCs in treating osteoarthritis, but this is one of the first clinical trials directly comparing this approach to standard treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 35 and 70 years-old * Patient is scheduled to undergo one or a combination of the following procedures: * Meniscal debridement or partial menisectomy * Meniscal repair that does not necessitate a different postoperative protocol from meniscal debridement or partial menisectomy * Removal of loose bodies * Chondroplasty * Synovectomy * Soft tissue releases for flexion or extension contracture. * Diagnosis of pre-existing mild to moderate osteoarthritis of the medial or lateral femoral condyle (Kellgren-Lawrence Grade 2 or 3) * \< 6 months of knee pain or \< 6 months of a significant exacerbation of existing knee pain * Physical examination findings consistent with the proposed surgical procedure. * Failure of conservative therapy consisting of a minimum of 6 weeks of physical therapy and trial of anti-inflammatory medications, with or without concomitant bracing and/or injections Exclusion Criteria: * Age \< 35 or \> 70 years old * Radiographs demonstrating either no, little or severe osteoarthritis (Kellgren-Lawrence Grade 0, 1 or 4) * Previous injury or surgery to the infrapatellar fat pad (assessed by MRI) * Patient scheduled to undergo any concomitant surgical procedures with the exception of: * Meniscal debridement or partial menisectomy * Meniscal repair that does not necessitate a different postoperative protocol from meniscal debridement or partial menisectomy * Removal of loose bodies * Chondroplasty * Synovectomy * Soft tissue releases for flexion or extension contracture * Prior surgery on ipsilateral knee involving cartilage regeneration (microfracture, Autologous Chondrocyte Implantation, etc) or meniscal transplant/implant * Previous arthroscopy within 1 year * Subchondral edema
Where this trial is running
Santa Monica, California and 2 other locations
- Kerlan Jobe Orthopedic Institute — Santa Monica, California, United States (RECRUITING)
- Stanford University — Stanford, California, United States (ACTIVE_NOT_RECRUITING)
- UC Health Steadman Hawkins Clinic - Denver Inverness — Denver, Colorado, United States (RECRUITING)
Study contacts
- Principal investigator: Jason L Dragoo, MD — University of Colorado, Denver
- Study coordinator: Kaitlyn Whitney
- Email: Inverness.clinicaltrials@cuanschutz.edu
- Phone: (720) 872-4836
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Knee Osteoarthritis, stem cell, knee pain, osteoarthritis, arthritis, ADSC, fat stem cell