The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis

The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis: A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Procedure: Arthroscopic debridement with stem cell transplantation; Procedure: Arthroscopic debridement only

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
• Enrollment (Estimated): 29
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kaitlyn Whitney; Phone Number: (720) 872-4836; Email: Inverness.clinicaltrials@cuanschutz.edu

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • Recruiting
      • Kerlan Jobe Orthopedic Institute
      • Contact: Jasmine Galloway, B.S.; Phone Number: 310-829-2663; Email: jasmine.galloway@cskerlanjobe.org
      • Sub-Investigator: Burt Mandelbaum, M.D.
    • Stanford, California, United States, 94305
      • Active, not recruiting
      • Stanford University
  • Colorado
    • Denver, Colorado, United States, 80112
      • Recruiting
      • UC Health Steadman Hawkins Clinic - Denver Inverness
      • Contact: Kaitlyn Whitney; Phone Number: 720-872-4836; Email: Inverness.clinicaltrial@cuanschutz.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative KOOS (Knee Injury and Osteoarthritis Outcome Score) score 24 months following surgery	Patient reported outcomes measures; Score ranges 0-100, with 100 being healthy/normal	The study will end after 24 month follow-up is completed in all participants.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tegner score	Patient reported outcomes measures	6, 12, 24 months
Lysholm score	Patient reported outcomes measures	6, 12, 24 months
VR-12	Patient reported outcomes measures	6, 12, 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI scans -	Average cartilage thickness. Defect fill (percent) routine clinical sequences, T2, T1p	1, 12, 24 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Stanford University
• Investigators: Principal Investigator: Jason L Dragoo, MD, University of Colorado - Anschutz Medical Campus; Principal Investigator: Seth L Sherman, MD, Stanford University

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 20, 2016
• First Submitted That Met QC Criteria: January 5, 2017
• First Posted (Estimated): January 9, 2017

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: osteoarthritis; stem cell; knee pain; arthritis; ADSC; fat stem cell
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 19-2893

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO