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NCT03014401 | RECRUITING | Knee Osteoarthritis

The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis
Sponsor:

University of Colorado, Denver

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.

Condition or disease

Knee Osteoarthritis

Intervention/treatment

Arthroscopic debridement with stem cell transplantation

Arthroscopic debridement only

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 29 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis: A Randomized Controlled Trial
Actual Study Start Date : 2016-05
Estimated Primary Completion Date : 2025-12
Estimated Study Completion Date : 2025-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 35 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis

Location Details

NCT03014401

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Kerlan Jobe Orthopedic Institute

Santa Monica, California, United States, 90404

ACTIVE NOT RECRUITING

United States, California

Stanford University

Stanford, California, United States, 94305

RECRUITING

United States, Colorado

UC Health Steadman Hawkins Clinic - Denver Inverness

Denver, Colorado, United States, 80112