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

Primary Purpose

Osteoarthritis Shoulder, Shoulder Pain

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Micro Fragmented Adipose Tissue
Corticosteroid injection
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis Shoulder

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MFAT (Micro Fragmented Adipose Tissue)

Conventional Therapy

Arm Description

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.

Intra-articular injection of corticosteroid (Triamcinolone 40mg)

Outcomes

Primary Outcome Measures

ASES Shoulder Score
Patient reported outcome measure that reports shoulder pain and shoulder functionality

Secondary Outcome Measures

DASH Outcome Measure
Patient reported questionnaire that measures physical function and symptoms
Veterans RAND 12 (VR-12) score
Patient reported quality of life outcome measure on a scale of 0-50 with 50 being healthy

Full Information

First Posted
June 4, 2021
Last Updated
September 15, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04929951
Brief Title
The Effect of Micro Fragmented Adipose Tissue (MFAT) on Shoulder Osteoarthritis
Official Title
The Effect of Micro Fragmented Adipose Tissue (MFAT) on Shoulder Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis Shoulder, Shoulder Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Micro Fragmented Adipose Tissue (MFAT) on Shoulder Osteoarthritis
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MFAT (Micro Fragmented Adipose Tissue)
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional Therapy
Arm Type
Active Comparator
Arm Description
Intra-articular injection of corticosteroid (Triamcinolone 40mg)
Intervention Type
Biological
Intervention Name(s)
Micro Fragmented Adipose Tissue
Other Intervention Name(s)
MFAT
Intervention Description
Harvesting of Micro Fragmented Adipose Tissue with intra-articular injection
Intervention Type
Biological
Intervention Name(s)
Corticosteroid injection
Intervention Description
Sham harvesting of adipose tissue without intra-articular injection. Intra-articular injection of corticosteroid.
Primary Outcome Measure Information:
Title
ASES Shoulder Score
Description
Patient reported outcome measure that reports shoulder pain and shoulder functionality
Time Frame
24 Months
Secondary Outcome Measure Information:
Title
DASH Outcome Measure
Description
Patient reported questionnaire that measures physical function and symptoms
Time Frame
24 Months
Title
Veterans RAND 12 (VR-12) score
Description
Patient reported quality of life outcome measure on a scale of 0-50 with 50 being healthy
Time Frame
24 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannon Schultz, BA
Phone
650-723-2897
Email
sks01@stanford.edu
First Name & Middle Initial & Last Name & Degree
Eugene Y Roh, MD
First Name & Middle Initial & Last Name & Degree
Geoffrey D Abrams, MD

12. IPD Sharing Statement

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

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