beta
Trial Radar AI
Clinical Trial NCT04929951 for Osteoarthritis Shoulder, Shoulder Pain is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One study matched filter criteria
Card View
Back to Search

The Effect of Micro Fragmented Adipose Tissue (MFAT) on Shoulder Osteoarthritis Phase 1 48

Recruiting
Clinical Trial NCT04929951 is designed to study Treatment for Osteoarthritis Shoulder, Shoulder Pain. It is a Phase 1 interventional study that is recruiting, having started on July 28, 2022, with plans to enroll 48 participants. Led by Stanford University, it is expected to complete by December 31, 2027. The latest data from ClinicalTrials.gov was last updated on October 30, 2025.
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.
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 manipulat...Show More
Official Title

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

Conditions
Osteoarthritis ShoulderShoulder Pain
Other Study IDs
  • 59461
NCT ID Number
NCT04929951
Start Date (Actual)
2022-07-28
Last Update Posted
2025-10-30
Completion Date (Estimated)
2027-12-31
Enrollment (Estimated)
48
Study Type
Interventional
PHASE
Phase 1
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalMFAT (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.
Micro Fragmented Adipose Tissue
Harvesting of Micro Fragmented Adipose Tissue with intra-articular injection
Active ComparatorConventional Therapy
Intra-articular injection of corticosteroid (Triamcinolone 40mg)
Corticosteroid injection
Sham harvesting of adipose tissue without intra-articular injection. Intra-articular injection of corticosteroid.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
ASES Shoulder Score
Patient reported outcome measure that reports shoulder pain and shoulder functionality
24 Months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
DASH Outcome Measure
Patient reported questionnaire that measures physical function and symptoms
24 Months
Veterans RAND 12 (VR-12) score
Patient reported quality of life outcome measure on a scale of 0-50 with 50 being healthy
24 Months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
25 Years
Eligible Sexes
All
  • 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.

  • 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
Stanford University logoStanford University665 active studies to explore
Study Responsible Party
Eugene Roh, Principal Investigator, Clinical Associate Professor, Stanford University
No contact data.
1 Study Locations in 1 Countries

California

Stanford University, Stanford, California, 94305, United States
Jessica Nguyen, BS, Contact, (650)723-0003, [email protected]
Elizabeth(Telsie) Jameiro, MD, Contact, (650)723-0003, [email protected]
Eugene Y Roh, MD, Principal Investigator
Geoffrey D Abrams, MD, Principal Investigator
Recruiting