The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03014401
• Other study ID #: 19-2893
• Status: Recruiting
• Phase: N/A
• Start date: May 2016
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: University of Colorado, Denver
• Contact: Kaitlyn Whitney
• Phone: (720) 872-4836
• Email: Inverness.clinicaltrials[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 29
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.
• Arthroscopic debridement only
standard arthroscopic treatment consisting of: partial meniscectomy, synovectomy, chondroplasty, loose body removal.

Locations

Country	Name	City	State
United States	UC Health Steadman Hawkins Clinic - Denver Inverness	Denver	Colorado
United States	Kerlan Jobe Orthopedic Institute	Santa Monica	California
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	MRI scans -	Average cartilage thickness. Defect fill (percent) routine clinical sequences, T2, T1p	1, 12, 24 months
Primary	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	Tegner score	Patient reported outcomes measures	6, 12, 24 months
Secondary	Lysholm score	Patient reported outcomes measures	6, 12, 24 months
Secondary	VR-12	Patient reported outcomes measures	6, 12, 24 months