NCT04929951

The Effect of Micro Fragmented Adipose Tissue (MFAT) on Shoulder Osteoarthritis

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 25 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a non-surgical trial comparing the clinical and functional outcomes of patients with osteoarthritis treated with Intra-articular injection of Micro Fragmented Adipose Tissue versus conventional therapy of intra-articular injection of corticosteroid.

Detailed description

This study will be a randomized controlled trial to compare outcomes between intra-articular injection of Micro Fragmented Adipose Tissue and intra-articular injection of corticosteroid in patients with mild to moderate osteoarthritis of the shoulder. Micro Fragmented Adipose Tissue will be harvested at the subcutaneous tissue by lipoaspiration. Once fat tissue is obtained, it will be processed with minimal manipulation in the clinic room. To be considered for participation in this study, patients must have radiographic evidence of mild to moderate osteoarthritis of the shoulder (glenohumeral joint). In addition, patients must meet several inclusion/exclusion criteria to be randomized and included in this study.

Conditions

• Osteoarthritis Shoulder
• Shoulder Pain

Interventions

Type	Name	Description
BIOLOGICAL	Micro Fragmented Adipose Tissue	Harvesting of Micro Fragmented Adipose Tissue with intra-articular injection
BIOLOGICAL	Corticosteroid injection	Sham harvesting of adipose tissue without intra-articular injection. Intra-articular injection of corticosteroid.

Timeline

• Start date: 2022-07-28
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2021-06-18
• Last updated: 2025-10-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study