The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis

NCT03014401 | Recruiting

• 1 other identifier: 19-2893
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 3

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. 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. 2.Standard arthroscopic treatment (above) without cell transplant.

Conditions

Knee Osteoarthritis

Keywords

stem cell; knee pain; osteoarthritis; arthritis; ADSC; fat stem cell

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Tegner score

  6, 12, 24 months

• Lysholm score

  6, 12, 24 months

• VR-12

  6, 12, 24 months

Other Outcomes (1)

• MRI scans -

  1, 12, 24 months

Study Arms (2)

Stem Cells

EXPERIMENTAL

Fat pad harvest with stem cell transplantation and standard arthroscopic debridement.

Procedure: Arthroscopic debridement with stem cell transplantation

Placebo

ACTIVE COMPARATOR

Standard arthroscopic debridement with fat pad harvest WITHOUT stem cell transplantation

Procedure: Arthroscopic debridement only

Interventions

Arthroscopic debridement with stem cell transplantation PROCEDURE

Autologous fat pad harvest and transplantation of cells after standard arthroscopic treatment consisting of: partial meniscectomy, synovectomy, chondroplasty, loose body removal.

Stem Cells

Arthroscopic debridement only PROCEDURE

standard arthroscopic treatment consisting of: partial meniscectomy, synovectomy, chondroplasty, loose body removal.

Placebo

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Stanford University: collaborator

Study Sites (3)

Kerlan Jobe Orthopedic Institute

Santa Monica, California, 90404, United States

RECRUITING

Stanford University

Stanford, California, 94305, United States

ACTIVE NOT RECRUITING

UC Health Steadman Hawkins Clinic - Denver Inverness

Denver, Colorado, 80112, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Arthritis

Interventions

Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Jason L Dragoo, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Seth L Sherman, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaitlyn Whitney

CONTACT

(720) 872-4836; Inverness.clinicaltrials@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: January 9, 2017
• Study Start: May 1, 2016
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)