Recruiting
Phase 1

MFAT

Sponsor:

Stanford University

Code:

NCT04929951

Conditions

Osteoarthritis Shoulder

Shoulder Pain

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

Interventions

Micro Fragmented Adipose Tissue

Corticosteroid injection

Study Details

Brief 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.

Conditions

Osteoarthritis Shoulder

Shoulder Pain

Study ID

NCT04929951

Start date

Jul 28, 2022

Status verified date

Aug, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age between 25 and 75 years-old
  • Diagnosis of pre-existing osteoarthritis of the glenohumeral joint
  • Working understanding of the English language and able to fully understand the procedure
  • Capable of providing informed consent
  • Able to complete online, in-person or phone surveys for the purposes of follow-up
  • Capable of understanding pre- and post-procedure care instructions
  • Ambulatory at baseline
  • Previous trial and failure of conservative therapy consisting of a minimum of 6 weeks of physical therapy and trial of anti-inflammatory medications if not contraindicated, with or without concomitant bracing and/or injections.

Exclusion Criteria:

  • Age < 25 or > 75 years old
  • Radiographs demonstrating either no, little osteoarthritis, severe(bone on bone) osteoarthritis
  • Prior total or partial joint replacement surgery or surgery involving cartilage regeneration
  • Previous cortisone, PRP or Hyaluronic acid intra-articular injection within the last 3 months
  • Co-morbidity with the rheumatologic condition, inflammatory arthritis
  • Currently undergoing immunomodulatory therapy
  • Uncontrolled endocrine disorder
  • BMI >40 or joint space not visible by ultrasound
  • Current diagnosis of osteomyelitis, human immunodeficiency virus (HIV-1, -2) and/or hepatitis C (HCV), infection, and poorly controlled diabetes (HgA1C >7.0)
  • Pregnancy or planned pregnancy
  • previous stem cell injection into treatment joint
  • Patient scheduled to undergo any concomitant shoulder surgical procedures or other surgery which may affect outcomes.
  • Coagulopathy or anticoagulant treatment
  • Chronic pain involving multiple body parts or opioid medication management
  • Diagnosis of fibromyalgia
  • Concomitant massive(2 tendons with retraction), complete rotator cuff tendon tear

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MFAT (Micro Fragmented Adipose Tissue)

Intra-articular shoulder injection of autologous Micro Fragmented Adipose Tissue harvested from the thigh using tumescent lipoaspiration and processing with minimal manipulation. This harvested tissue will then be injected into the patient's shoulder.

active comparator: Conventional Therapy

Intra-articular injection of corticosteroid (Triamcinolone 40mg)

Interventions

Micro Fragmented Adipose Tissue

Harvesting of Micro Fragmented Adipose Tissue with intra-articular injection

Corticosteroid injection

Sham harvesting of adipose tissue without intra-articular injection. Intra-articular injection of corticosteroid.

Primary outcome measure

  • ASES Shoulder Score [ Time Frame: 24 Months ]

Central Contacts and Locations

Locations

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

Jessica Nguyen, BS

(650)723-0003jessn16@stanford.edu

Elizabeth(Telsie) Jameiro, MD

(650)723-0003ejameiro@stanford.edu

Principal Investigator:

Eugene Y Roh, MD

More Information

Sponsor

Stanford University

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-08-17.