Recruiting

Adipose-Derived Stem Cells

Sponsor:

University of Colorado, Denver

Code:

NCT03014401

Conditions

Knee Osteoarthritis

Eligibility Criteria

Sex: All

Age: 35 - 70

Healthy Volunteers: Not accepted

Interventions

Arthroscopic debridement with stem cell transplantation

Arthroscopic debridement only

Study Details

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.

Conditions

Knee Osteoarthritis

Study ID

NCT03014401

Start date

May, 2016

Status verified date

Apr, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

29 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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.

Arthroscopic debridement only

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

Primary outcome measure

  • Postoperative KOOS (Knee Injury and Osteoarthritis Outcome Score) score 24 months following surgery [ Time Frame: The study will end after 24 month follow-up is completed in all participants. ]

Central Contacts and Locations

Central contacts

Kaitlyn Whitney

(720) 872-4836Inverness.clinicaltrials@cuanschutz.edu

Locations

Kerlan Jobe Orthopedic Institute

Recruiting

Santa Monica, California, United States, 90404

Contacts

Jasmine Galloway, B.S.

310-829-2663jasmine.galloway@cskerlanjobe.org

UC Health Steadman Hawkins Clinic - Denver Inverness

Recruiting

Denver, Colorado, United States, 80112

Contacts

Kaitlyn Whitney

720-872-4836Inverness.clinicaltrial@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Apr 25, 2024

Last verified

Apr, 2024

Keywords

  • stem cell
  • knee pain
  • osteoarthritis
  • arthritis
  • ADSC
  • fat stem cell

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2024-04-25.