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| Name | Class |
|---|---|
| Stanford University | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stem Cells | Experimental | Fat pad harvest with stem cell transplantation and standard arthroscopic debridement. |
|
| Placebo | Active Comparator | Standard arthroscopic debridement with fat pad harvest WITHOUT stem cell transplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arthroscopic debridement with stem cell transplantation | Procedure | Autologous fat pad harvest and transplantation of cells after standard arthroscopic treatment consisting of: partial meniscectomy, synovectomy, chondroplasty, loose body removal. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative KOOS (Knee Injury and Osteoarthritis Outcome Score) score 24 months following surgery | Patient reported outcomes measures; Score ranges 0-100, with 100 being healthy/normal | The study will end after 24 month follow-up is completed in all participants. |
| Measure | Description | Time Frame |
|---|---|---|
| Tegner score | Patient reported outcomes measures | 6, 12, 24 months |
| Lysholm score | Patient reported outcomes measures | 6, 12, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| MRI scans - | Average cartilage thickness. Defect fill (percent) routine clinical sequences, T2, T1p | 1, 12, 24 months |
Inclusion Criteria:
Age between 35 and 70 years-old
Patient is scheduled to undergo one or a combination of the following procedures:
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:
Prior surgery on ipsilateral knee involving cartilage regeneration (microfracture, Autologous Chondrocyte Implantation, etc) or meniscal transplant/implant
Previous arthroscopy within 1 year
Subchondral edema
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kaitlyn Whitney | Contact | (720) 872-4836 | Inverness.clinicaltrials@cuanschutz.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jason L Dragoo, MD | University of Colorado, Denver | Principal Investigator |
| Seth L Sherman, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kerlan Jobe Orthopedic Institute | Recruiting | Santa Monica | California | 90404 | United States |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D033581 | Stem Cell Transplantation |
| ID | Term |
|---|---|
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| Arthroscopic debridement only | Procedure | standard arthroscopic treatment consisting of: partial meniscectomy, synovectomy, chondroplasty, loose body removal. |
|
| VR-12 | Patient reported outcomes measures | 6, 12, 24 months |
| Stanford University | Active, not recruiting | Stanford | California | 94305 | United States |
| UC Health Steadman Hawkins Clinic - Denver Inverness | Recruiting | Denver | Colorado | 80112 | United States |
|
| D014180 |
| Transplantation |
| D013514 | Surgical Procedures, Operative |