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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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: 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Kerlan Jobe Orthopedic Institute
RECRUITING
Santa Monica
Stanford University
ACTIVE_NOT_RECRUITING
Stanford
Colorado
UC Health Steadman Hawkins Clinic - Denver Inverness
RECRUITING
Denver
Contact Information
Primary
Kaitlyn Whitney
Inverness.clinicaltrials@cuanschutz.edu
(720) 872-4836
Time Frame
Start Date: 2016-05
Estimated Completion Date: 2025-12
Participants
Target number of participants: 29
Treatments
Experimental: Stem Cells
Fat pad harvest with stem cell transplantation and standard arthroscopic debridement.
Active_comparator: Placebo
Standard arthroscopic debridement with fat pad harvest WITHOUT stem cell transplantation
Related Therapeutic Areas
Sponsors
Collaborators: Stanford University
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov