The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis

Last updated: April 24, 2024
Sponsor: University of Colorado, Denver
Overall Status: Active - Recruiting

Phase

N/A

Condition

Knee Injuries

Osteoarthritis

Treatment

Arthroscopic debridement with stem cell transplantation

Arthroscopic debridement only

Clinical Study ID

NCT03014401
19-2893
  • Ages 35-70
  • All Genders

Study 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 Criteria

Inclusion

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 frommeniscal 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 lateralfemoral condyle (Kellgren-Lawrence Grade 2 or 3)
  • < 6 months of knee pain or < 6 months of a significant exacerbation of existing kneepain
  • Physical examination findings consistent with the proposed surgical procedure.
  • Failure of conservative therapy consisting of a minimum of 6 weeks of physical therapyand trial of anti-inflammatory medications, with or without concomitant bracing and/orinjections

Exclusion

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 exceptionof:
  • Meniscal debridement or partial menisectomy
  • Meniscal repair that does not necessitate a different postoperative protocol frommeniscal 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

Total Participants: 29
Treatment Group(s): 2
Primary Treatment: Arthroscopic debridement with stem cell transplantation
Phase:
Study Start date:
May 01, 2016
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Kerlan Jobe Orthopedic Institute

    Santa Monica, California 90404
    United States

    Active - Recruiting

  • Stanford University

    Stanford, California 94305
    United States

    Site Not Available

  • UC Health Steadman Hawkins Clinic - Denver Inverness

    Denver, Colorado 80112
    United States

    Active - Recruiting

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