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The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03014401
Recruitment Status : Recruiting
First Posted : January 9, 2017
Last Update Posted : May 24, 2023
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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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 Intervention/treatment Phase
Knee Osteoarthritis Procedure: Arthroscopic debridement with stem cell transplantation Procedure: Arthroscopic debridement only Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis: A Randomized Controlled Trial
Study Start Date : May 2016
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Stem Cells
Fat pad harvest with stem cell transplantation and standard arthroscopic debridement.
 Procedure: 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.
Active Comparator: Placebo
Standard arthroscopic debridement with fat pad harvest WITHOUT stem cell transplantation
 Procedure: Arthroscopic debridement only
standard arthroscopic treatment consisting of: partial meniscectomy, synovectomy, chondroplasty, loose body removal.


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]
    Patient reported outcomes measures; Score ranges 0-100, with 100 being healthy/normal


Secondary Outcome Measures :
  1. Tegner score [ Time Frame: 6, 12, 24 months ]
    Patient reported outcomes measures

  2. Lysholm score [ Time Frame: 6, 12, 24 months ]
    Patient reported outcomes measures

  3. VR-12 [ Time Frame: 6, 12, 24 months ]
    Patient reported outcomes measures


Other Outcome Measures:
  1. MRI scans - [ Time Frame: 1, 12, 24 months ]
    Average cartilage thickness. Defect fill (percent) routine clinical sequences, T2, T1p


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03014401


Contacts
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Contact: Veronica Butler (720)872-0112 dragoo.lab@ucdenver.edu
Contact: Kaitie Whitney (720)872-0112 dragoo.lab@ucdenver.edu

Locations
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United States, California
Kerlan Jobe Orthopedic Institute Recruiting
Santa Monica, California, United States, 90404
Contact: Jasmine Galloway, B.S.    310-829-2663    jasmine.galloway@cskerlanjobe.org   
Sub-Investigator: Burt Mandelbaum, M.D.         
Stanford University Active, not recruiting
Stanford, California, United States, 94305
United States, Colorado
UC Health Steadman Hawkins Clinic - Denver Inverness Recruiting
Denver, Colorado, United States, 80112
Contact: Veronica Butler    720-872-0112    dragoo.lab@ucdenver.edu   
Contact: Kaitie Whitney    (720)872-0112    dragoo.lab@ucdenver.edu   
Sponsors and Collaborators
University of Colorado, Denver
Stanford University
Investigators
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Principal Investigator: Jason L Dragoo, MD University of Colorado - Anschutz Medical Campus
Principal Investigator: Seth L Sherman, MD Stanford University
More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03014401    
Other Study ID Numbers: 19-2893
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: May 24, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Colorado, Denver:
stem cell
knee pain
osteoarthritis
 arthritis
ADSC
fat stem cell
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases