The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis

Study Overview
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Brief Summary
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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: 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. Standard arthroscopic treatment (above) without cell transplant.

Detailed Description
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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.

Official Title
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The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis: A Randomized Controlled Trial

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Procedure: Arthroscopic debridement with stem cell transplantation
* Procedure: Arthroscopic debridement only


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stem Cells<br>Fat pad harvest with stem cell transplantation and standard arthroscopic debridement. | Procedure: Arthroscopic debridement with stem cell transplantation<br>* Autologous fat pad harvest and transplantation of cells after standard arthroscopic treatment consisting of: partial meniscectomy, synovectomy, chondroplasty, loose body removal.<br>|
| Active Comparator: Placebo<br>Standard arthroscopic debridement with fat pad harvest WITHOUT stem cell transplantation | Procedure: Arthroscopic debridement only<br>* standard arthroscopic treatment consisting of: partial meniscectomy, synovectomy, chondroplasty, loose body removal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tegner score | Patient reported outcomes measures | 6, 12, 24 months | 
| Lysholm score | Patient reported outcomes measures | 6, 12, 24 months | 
| VR-12 | Patient reported outcomes measures | 6, 12, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADSC, stem cell, knee pain, osteoarthritis, arthritis, fat stem cell