The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis

Not Applicable

Recruiting

• Conditions: Knee Osteoarthritis
• Interventions: Procedure: Arthroscopic debridement only; Procedure: Arthroscopic debridement with stem cell transplantation

• Registration Number: NCT03014401
• Lead 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.

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 Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-12-20
• Study First Submitted QC: 2017-01-05
• Study First Posted: 2017-01-09
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-25
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 29

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Arthroscopic debridement only	Standard arthroscopic debridement with fat pad harvest WITHOUT stem cell transplantation
Stem Cells	Arthroscopic debridement with stem cell transplantation	Fat pad harvest with stem cell transplantation and standard arthroscopic debridement.

Primary Outcome Measures

Name	Time	Method
Postoperative KOOS (Knee Injury and Osteoarthritis Outcome Score) score 24 months following surgery	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

Name	Time	Method
Tegner score	6, 12, 24 months	Patient reported outcomes measures
Lysholm score	6, 12, 24 months	Patient reported outcomes measures
VR-12	6, 12, 24 months	Patient reported outcomes measures

Trial Locations

Locations (3)

Kerlan Jobe Orthopedic Institute; 🇺🇸 Santa Monica, California, United States

UC Health Steadman Hawkins Clinic - Denver Inverness; 🇺🇸 Denver, Colorado, United States

Stanford University; 🇺🇸 Stanford, California, United States