The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis

NCT ID: NCT03014401

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2025-12-31

Brief 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.

Detailed Description

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Stem Cells

Fat pad harvest with stem cell transplantation and standard arthroscopic debridement.

Group Type: EXPERIMENTAL

Arthroscopic debridement with stem cell transplantation

Intervention Type: PROCEDURE

Autologous fat pad harvest and transplantation of cells after standard arthroscopic treatment consisting of: partial meniscectomy, synovectomy, chondroplasty, loose body removal.

Placebo

Standard arthroscopic debridement with fat pad harvest WITHOUT stem cell transplantation

Group Type: ACTIVE_COMPARATOR

Arthroscopic debridement only

Intervention Type: PROCEDURE

standard arthroscopic treatment consisting of: partial meniscectomy, synovectomy, chondroplasty, loose body removal.

Interventions

Arthroscopic debridement with stem cell transplantation

Autologous fat pad harvest and transplantation of cells after standard arthroscopic treatment consisting of: partial meniscectomy, synovectomy, chondroplasty, loose body removal.

Intervention Type: PROCEDURE

Arthroscopic debridement only

standard arthroscopic treatment consisting of: partial meniscectomy, synovectomy, chondroplasty, loose body removal.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason L Dragoo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Seth L Sherman, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Kerlan Jobe Orthopedic Institute

Santa Monica, California, United States

Site Status: RECRUITING

Stanford University

Stanford, California, United States

Site Status: ACTIVE_NOT_RECRUITING

UC Health Steadman Hawkins Clinic - Denver Inverness

Denver, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kaitlyn Whitney

Role: CONTACT

Inverness.clinicaltrials@cuanschutz.edu

(720) 872-4836

Facility Contacts

Jasmine Galloway, B.S.

Role: primary

jasmine.galloway@cskerlanjobe.org

310-829-2663

Kaitlyn Whitney

Role: primary

Inverness.clinicaltrial@cuanschutz.edu

720-872-4836

Other Identifiers

19-2893

Identifier Type: -

Identifier Source: org_study_id