The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis
Study Details
Study Description
Brief Summary
The purpose of this study is to compare the clinical and functional outcomes of patients with mild to moderate arthroscopically confirmed osteoarthritis between the following two groups:
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Partial fat pad harvest with Adipose-Derived Stem Cell (ADSC) transplantation with standard arthroscopic treatment consisting of: partial meniscectomy, cartilage stabilization, loose body removal and selective synovectomy.
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Standard arthroscopic treatment (above) with out cell transplant.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Adipose-derived stem cells (ADSC) may be beneficial to patients with OA because they may differentiate into chondrocytes, promote endogenous tissue repair, and have potent anti-inflammatory properties.
Early studies show promising clinical results using ADSCs to treat patients with osteoarthritis, but no clinical trials have been completed comparing cellular therapy to standard arthroscopic treatment.
The investigators aim to determine whether ADSC transplantation as adjuvant therapy in patients with arthroscopic findings of mild to moderate arthritis will result in improved clinical outcomes scores at one and two-year follow-up compared to standard arthroscopic treatment.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Stem Cells Fat pad harvest with stem cell transplantation and standard arthroscopic debridement. |
Procedure: Arthroscopic debridement with stem cell transplantation
Autologous fat pad harvest and transplantation of cells after standard arthroscopic treatment consisting of: partial meniscectomy, synovectomy, chondroplasty, loose body removal.
|
| Active Comparator: Placebo Standard arthroscopic debridement with fat pad harvest WITHOUT stem cell transplantation |
Procedure: Arthroscopic debridement only
standard arthroscopic treatment consisting of: partial meniscectomy, synovectomy, chondroplasty, loose body removal.
|
Outcome Measures
Primary Outcome Measures
- Postoperative KOOS (Knee Injury and Osteoarthritis Outcome Score) score 24 months following surgery [The study will end after 24 month follow-up is completed in all participants.]
Patient reported outcomes measures; Score ranges 0-100, with 100 being healthy/normal
Secondary Outcome Measures
- Tegner score [6, 12, 24 months]
Patient reported outcomes measures
- Lysholm score [6, 12, 24 months]
Patient reported outcomes measures
- VR-12 [6, 12, 24 months]
Patient reported outcomes measures
Other Outcome Measures
- MRI scans - [1, 12, 24 months]
Average cartilage thickness. Defect fill (percent) routine clinical sequences, T2, T1p
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age between 35 and 70 years-old
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Patient is scheduled to undergo one or a combination of the following procedures:
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Meniscal debridement or partial menisectomy
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Meniscal repair that does not necessitate a different postoperative protocol from meniscal debridement or partial menisectomy
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Removal of loose bodies
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Chondroplasty
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Synovectomy
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Soft tissue releases for flexion or extension contracture.
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Diagnosis of pre-existing mild to moderate osteoarthritis of the medial or lateral femoral condyle (Kellgren-Lawrence Grade 2 or 3)
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< 6 months of knee pain or < 6 months of a significant exacerbation of existing knee pain
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Physical examination findings consistent with the proposed surgical procedure.
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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:
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Age < 35 or > 70 years old
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Radiographs demonstrating either no, little or severe osteoarthritis (Kellgren-Lawrence Grade 0, 1 or 4)
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Previous injury or surgery to the infrapatellar fat pad (assessed by MRI)
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Patient scheduled to undergo any concomitant surgical procedures with the exception of:
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Meniscal debridement or partial menisectomy
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Meniscal repair that does not necessitate a different postoperative protocol from meniscal debridement or partial menisectomy
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Removal of loose bodies
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Chondroplasty
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Synovectomy
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Soft tissue releases for flexion or extension contracture
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Prior surgery on ipsilateral knee involving cartilage regeneration (microfracture, Autologous Chondrocyte Implantation, etc) or meniscal transplant/implant
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Previous arthroscopy within 1 year
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Subchondral edema
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kerlan Jobe Orthopedic Institute | Santa Monica | California | United States | 90404 |
| 2 | Stanford University | Stanford | California | United States | 94305 |
| 3 | UC Health Steadman Hawkins Clinic - Denver Inverness | Denver | Colorado | United States | 80112 |
Sponsors and Collaborators
- University of Colorado, Denver
- Stanford University
Investigators
- Principal Investigator: Jason L Dragoo, MD, University of Colorado - Anschutz Medical Campus
- Principal Investigator: Seth L Sherman, MD, Stanford University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19-2893