The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis

Trial ID or NCT#

NCT03014401

Status

recruiting iconRECRUITING

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

Ages Eligible for Study: 35 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
  1. * Age between 35 and 70 years-old* Patient is scheduled to undergo one or a combination of the following procedures:
  2. * 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:
  1. * 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:
  2. * 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
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Investigator(s)

Seth Lawrence Sherman, MD
Seth Lawrence Sherman, MD
Sports medicine surgeon, Shoulder surgeon, Orthopaedic surgeon
Associate Professor of Orthopaedic Surgery

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Contact

Jason L Dragoo, MD

View on ClinicalTrials.gov