Autologous Culture Expanded Mesenchymal Stromal Cells for Knee Osteoarthritis

Phase 1

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Drug: Autologous Adipose-Derived Mesenchymal Stromal Cells

• Registration Number: NCT02805855
• Lead Sponsor: Jacob L. Sellon, M.D.

Brief Summary

The study seeks to determine the safety and feasibility of using adipose-derived mesenchymal stromal cells to treat symptoms of mild to severe knee osteoarthritis.

Detailed Description

Interventions to alter the natural course of osteoarthritis (OA) in the knee are elusive and joint replacement remains the definitive management for refractory, end-stage disease. The Mayo Clinic has a large, ongoing experience using autologous adipose derived mesenchymal stromal cells (AMSCs) for the treatment of a variety of other diseases under INDs. Thus far, the treatments have been well tolerated. These data along with the investigators' pre-clinical animal studies and published experiences using related approaches lead the investigators to believe that this approach provides a reasonable safety profile to treat patients with refractory painful knee OA. The purpose of the current study is to investigate the safety and feasibility of single and multiple injections of autologous, culture expanded AMSCs in subjects with painful, refractory knee OA. Subjects with unilaterally symptomatic mild to severe knee OA will be enrolled based on satisfaction of inclusion and exclusion criteria.

Study Timeline

• Study First Submitted: 2016-06-16
• Study First Submitted QC: 2016-06-16
• Study First Posted: 2016-06-20
• Study Start: 2016-10-26
• Primary Completion: 2023-09-28
• Study Completion: 2023-09-28
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-05
• Last Update Posted: 2023-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
S50	Autologous Adipose-Derived Mesenchymal Stromal Cells	Subjects in the S50 cohort will receive one injection of 50 million AMSCs.
S100	Autologous Adipose-Derived Mesenchymal Stromal Cells	Subjects in the S100 cohort will receive one injection of 100 million AMSCs.
M50	Autologous Adipose-Derived Mesenchymal Stromal Cells	Subjects in the M50 cohort will receive three injections of 50 million AMSCs at one-month intervals.
M100	Autologous Adipose-Derived Mesenchymal Stromal Cells	Subjects in the M100 cohort will receive three injections of 100 million AMSCs at one-month intervals.

Primary Outcome Measures

Name	Time	Method
Number of subjects experiencing adverse events.	2 years post final injection	Assess the local and systemic safety of single and multiple injections of human, autologous, culture expanded AMSCs in the treatment of symptomatic knee OA.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States