The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis
Trial ID or NCT#
Status
Purpose
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: 1. 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. 2. Standard arthroscopic treatment (above) without cell transplant.
Official Title
The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis: A Randomized Controlled Trial
Eligibility 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
- * 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
Investigator(s)
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Contact
Jason L Dragoo, MD
View on ClinicalTrials.gov