Osteoarthritis, KneePhase 3NCT03467919

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

A Phase 3 study testing Micro Fragmented Adipose Tissue and Corticosteroid injection in people with Osteoarthritis, Knee and Knee Pain, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 35 to 75 years
Conditions the study is for: Osteoarthritis, Knee, Knee Pain
What is being tested?: Micro Fragmented Adipose Tissue and Corticosteroid injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 1 Apr 2018to 29 Oct 2024
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age between 35 and 75 years-old
Diagnosis of pre-existing osteoarthritis of the joint by Kellgren-Lawrence Grade 2 or 3.
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.

Who cannot join

Age < 35 or > 75 years old
Radiographs demonstrating either no, little or severe osteoarthritis (Kellgren-Lawrence Grade 0, 1 )
Prior total or partial joint replacement surgery or a surgery involving cartilage regeneration (microfracture, ACI, etc)
Previous cortisone and/or Hyaluronic acid intra-articular injection within the last 3 months
Co-morbidity with rheumatologic condition, inflammatory arthritis
Currently undergoing immunomodulatory therapy

Show all 14Show fewer

Uncontrolled endocrine disorder
BMI >35
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 surgical procedures.
Coagulopathy or anticoagulant treatment
Chronic pain involving multiple body parts or opioid medication management

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University
Stanford, California, 94305

Other trials in United States

About this study

Read the 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 knee. 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 medial and/or lateral weight-bearing compartments (Kellgren-Lawrence Grade 2 or 3). In addition, patients must meet several inclusion/exclusion criteria to be randomized and included in this study.

Conditions: Osteoarthritis, Knee, Knee Pain
Being tested: Micro Fragmented Adipose Tissue, Corticosteroid injection
Keywords: osteoarthritis, stem cell, knee pain, adipose derived stem cell, injection, MFAT, Micro Fragmented Adipose Tissue
Medical subject headings: Osteoarthritis, Knee, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Micro Fragmented Adipose TissueBiological
Also called MFAT
Harvesting of Micro Fragmented Adipose Tissue with intra-articular injection
Corticosteroid injectionBiological
Sham harvesting of adipose tissue without intra-articular injection. Intra-articular injection of corticosteroid.

Study groups in NCT03467919
Study group	Role	What they receive
MFAT(Micro Fragmented Adipose Tissue)	Experimental	Intra-articular knee 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 knee. Micro Fragmented Adipose Tissue: Harvesting of Micro Fragmented Adipose Tissue with intra-articular injection Receives: Biological: Micro Fragmented Adipose Tissue
Conventional therapy	Active comparator	Intra-articular injection of corticosteroid (Triamcinolone 40mg). Corticosteroid injection: Sham harvesting of adipose tissue without intra-articular injection. Intra-articular injection of corticosteroid. Receives: Biological: Corticosteroid injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Pain
Patient reported outcome measure that reports a normalized score (100 indicating no symptoms and 0 indicating extreme symptoms).
Measured: Baseline, 3, 6, 12, and 24 months
Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Symptoms
Patient reported outcome measure that reports a normalized score (100 indicating no symptoms and 0 indicating extreme symptoms).
Measured: Baseline, 3, 6, 12, and 24 months

Secondary outcomes (3)

Lysholm Score
Patient reported activity outcome measure on a scale of 0-100 (100 is best activity score)
Measured: Baseline, 3, 6, 12, and 24 months
Veterans RAND 12 (VR-12) Score - Physical
Patient reported quality of life outcome measure. VR-12 scores are reported as T-scores, which are standardized to have a mean of 50 and a standard deviation of 10 in the US population. Higher scores indicate better physical outcomes. Because this is a normalized range, there is theoretically no strict upper or lower bound. Most people will fall somewhere between 20-70 (+/- 3 SD).
Measured: Baseline, 3, 6, 12, and 24 months
Veterans RAND 12 (VR-12) Score - Mental
Patient reported quality of life outcome measure. VR-12 scores are reported as T-scores, which are standardized to have a mean of 50 and a standard deviation of 10 in the US population. Higher scores indicate better mental outcomes. Because this is a normalized range, there is theoretically no strict upper or lower bound. Most people will fall somewhere between 20-70 (+/- 3 SD).
Measured: Baseline, 3, 6, 12, and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 201829 Oct 2024

First posted16 Mar 2018
Study start1 Apr 2018
Primary completion29 Oct 2024
Study completion29 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Micro Fragmented Adipose Tissue (MFAT) on Knee Osteoarthritis
Masking: Single blind
Who is masked: Participant
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03467919
Sponsor's protocol ID: 41688
Status last verified: Dec 2025
First submitted: 20 Dec 2017
Last updated: 26 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
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All Osteoarthritis, Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Micro Fragmented Adipose Tissue (MFAT) on Knee Osteoarthritis
ClinicalTrials.gov ID: NCT03467919
Acronym / sponsor ID: 41688
Conditions: Osteoarthritis, Knee, Knee Pain
Keywords: osteoarthritis, stem cell, knee pain, adipose derived stem cell, injection, MFAT, Micro Fragmented Adipose Tissue
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Study start: 1 Apr 2018 (actual)
Primary completion: 29 Oct 2024 (actual)
Study completion: 29 Oct 2024 (actual)
First posted: 16 Mar 2018 (actual)
Results: Posted 26 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Micro Fragmented Adipose Tissue (MFAT) on Knee Osteoarthritis

Arm	Type	Receives
MFAT(Micro Fragmented Adipose Tissue)	Experimental	Biological: Micro Fragmented Adipose TissueIntra-articular knee 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 knee. Micro Fragmented Adipose Tissue: Harvesting of Micro Fragmented Adipose Tissue with intra-articular injection
Conventional therapy	Active comparator	Biological: Corticosteroid injectionIntra-articular injection of corticosteroid (Triamcinolone 40mg). Corticosteroid injection: Sham harvesting of adipose tissue without intra-articular injection. Intra-articular injection of corticosteroid.

Who may qualify

Ages: 35 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Age between 35 and 75 years-old
Diagnosis of pre-existing osteoarthritis of the joint by Kellgren-Lawrence Grade 2 or 3.
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

Key exclusion criteria (14 listed)

Age < 35 or > 75 years old
Radiographs demonstrating either no, little or severe osteoarthritis (Kellgren-Lawrence Grade 0, 1 )
Prior total or partial joint replacement surgery or a surgery involving cartilage regeneration (microfracture, ACI, etc)
Previous cortisone and/or Hyaluronic acid intra-articular injection within the last 3 months
Co-morbidity with rheumatologic condition, inflammatory arthritis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Micro Fragmented Adipose TissueAlso: MFATHarvesting of Micro Fragmented Adipose Tissue with intra-articular injection	Biological	MFAT(Micro Fragmented Adipose Tissue)
Corticosteroid injectionSham harvesting of adipose tissue without intra-articular injection. Intra-articular injection of corticosteroid.	Biological	Conventional therapy

Primary outcome

Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Pain
Time frame: Baseline, 3, 6, 12, and 24 months
Patient reported outcome measure that reports a normalized score (100 indicating no symptoms and 0 indicating extreme symptoms).
Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Symptoms
Time frame: Baseline, 3, 6, 12, and 24 months
Patient reported outcome measure that reports a normalized score (100 indicating no symptoms and 0 indicating extreme symptoms).

3 secondary outcomes

Lysholm Score
Time frame: Baseline, 3, 6, 12, and 24 months
Veterans RAND 12 (VR-12) Score - Physical
Time frame: Baseline, 3, 6, 12, and 24 months
Veterans RAND 12 (VR-12) Score - Mental
Time frame: Baseline, 3, 6, 12, and 24 months

Results and safety

Results posted to the registry on 26 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MFAT(Micro Fragmented Adipose Tissue)	30	27
Conventional Therapy	10	8

Primary outcome: Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Pain

Time frame: Baseline, 3, 6, 12, and 24 months. Mean (Standard Deviation). Unit: score on a scale

Measure	MFAT(Micro Fragmented Adipose Tissue) n = 29	Conventional Therapy n = 10	All Participants n = 39
Baseline	64.4 (17.0)	62.5 (21.3)	63.9 (17.9)
Change at 3 Months	13.2 (16.4)	8.6 (22.8)	12.0 (18.0)
Change at 6 Months	11.1 (13.8)	6.1 (21.2)	9.8 (15.9)
Change at 12 Months	10.8 (23.0)	14.2 (21.6)	11.6 (22.4)
Change at 24 Months	9.6 (18.7)	14.9 (26.8)	10.9 (20.6)

MFAT(Micro Fragmented Adipose Tissue) vs Conventional Therapy: p = 0.594, two-sample t-test
MFAT(Micro Fragmented Adipose Tissue) vs Conventional Therapy: p = 0.501, two-sample t-test
MFAT(Micro Fragmented Adipose Tissue) vs Conventional Therapy: p = 0.694, two-sample t-test

Population analysed: Participants with data at the respective time point.

Primary outcome: Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Symptoms

Time frame: Baseline, 3, 6, 12, and 24 months. Mean (Standard Deviation). Unit: score on a scale

Measure	MFAT(Micro Fragmented Adipose Tissue) n = 29	Conventional Therapy n = 10	All Participants n = 39
Baseline	49.0 (14.3)	47.5 (19.3)	48.6 (15.5)
Change at 3 Months	4.5 (13.3)	2.8 (24.9)	4.1 (16.6)
Change at 6 Months	7.2 (14.7)	6.1 (16.1)	7.0 (14.9)
Change at 12 Months	8.5 (18.1)	6.7 (17.2)	8.1 (17.6)
Change at 24 Months	5.9 (12.2)	13.8 (16.7)	7.8 (13.6)

MFAT(Micro Fragmented Adipose Tissue) vs Conventional Therapy: p = 0.847, two-sample t-test
MFAT(Micro Fragmented Adipose Tissue) vs Conventional Therapy: p = 0.839, two-sample t-test
MFAT(Micro Fragmented Adipose Tissue) vs Conventional Therapy: p = 0.791, two-sample t-test

Population analysed: Participants with data at the respective time point.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 2 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MFAT(Micro Fragmented Adipose Tissue)	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Conventional Therapy	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Osteoarthritis, Knee

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Eugene Y Roh, MD principal investigator

Stanford University

Jason Dragoo, MD principal investigator

Stanford University

Seth Sherman, MD principal investigator

Stanford University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Micro Fragmented Adipose Tissue and Corticosteroid injection in people with Osteoarthritis, Knee and Knee Pain, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Pain (time frame: Baseline, 3, 6, 12, and 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03467919.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.