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New treatment option for Osteoarthritis Shoulder
Official title The Effect of Micro Fragmented Adipose Tissue (MFAT) on Shoulder Osteoarthritis
ClinicalTrials.gov ID: NCT04929951
What this study is testing
What is Micro Fragmented Adipose Tissue?
Micro Fragmented Adipose Tissue is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for osteoarthritis shoulder.
Also referred to as MFAT.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 75
You may be able to join if
- 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
You likely can't join if
- Age \ 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
See the full eligibility 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...
- Age \ 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
The study team makes the final eligibility decision.
Where it's taking place
- Stanford, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 25 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stanford, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.