Micro-Fragmented Adipose Tissue (MFAT) for Arthritis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
NYU Langone Health, New York, NY
Arthritis
Micro-Fragmented Adipose Tissue (MFAT) - Biological
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether intraarticular injection of autologous adipose tissue is more effective than intraarticular corticosteroid injection in the treatment of CMC arthritis.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Micro-Fragmented Adipose Tissue (MFAT) will improve 1 primary outcome and 3 secondary outcomes in patients with Arthritis. Measurement will happen over the course of Baseline, Month 12.

Baseline, Month 12
Change in Kapandji Range of Motion Score
Change in Score on Thumb Disability Exam (TDX)
Change in Shortened Disabilities of the Arm, Shoulder, and Hand (QuickDASH) Score
Percent Change in Score on Pain Visual Analog Scale (VAS)

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Steroid (Control)
1 of 2
MFAT
1 of 2
Active Control
Experimental Treatment

This trial requires 32 total participants across 2 different treatment groups

This trial involves 2 different treatments. Micro-Fragmented Adipose Tissue (MFAT) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

MFAT
Biological
Steroid (Control)
Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, month 12
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, month 12 for reporting.

Closest Location

NYU Langone Health - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
18 years old or older; male and female patients
Eaton-Glickel stage 2-3 thumb CMC arthritis
Failed conservative treatment (i.e. hand therapy, pain medications, splinting)
Able to provide informed consent

Patient Q&A Section

What is the primary cause of arthritis?

"RA was found to be the most common joint disorder among the subjects under study. Ankylosing Spondylitis (AS), Osteoporosis (OP) and joint deformities were the most common secondary disorders reported. The most common cause reported was RA and the second most reported was AS. However, in the present study, other reported secondary causes were not significant. Overall findings of the present study indicated that the main causes of arthritis in the present study were not known." - Anonymous Online Contributor

Unverified Answer

What are the signs of arthritis?

"Joint pain associated with swollen joints can be a good indicator of arthritic conditions like [osteoarthritis](https://www.withpower.com/clinical-trials/osteoarthritis). Other indications of arthritic conditions include increased joint pain, swollen kneeweels, difficulty with movements like getting up and crossing one's legs, decreased range of motion, and stiffness of joints, among others. Arthritis is an underlying cause of many joint disorders such as fibromyalgia, lupus, rheumatoid arthritis and osteoarthritis." - Anonymous Online Contributor

Unverified Answer

How many people get arthritis a year in the United States?

"Overall, there are 927 million people in the U.S. that are projected to have arthritis at any given time. This number is expected to go up over time, as the national average rate is estimated to increase from 2% to 9% by 2050. Thus, there is a need to further understand the determinants of arthritis burden and to develop prevention strategies aimed at avoiding or reducing the incidence of this disease in the United States population. Based on previously estimated incidence rates, 4.5% will have RA by the year 2020 and 14% will have OA by 2050, indicating that arthritis is more prevalent in women. This sex difference in the prevalence of [osteoarthritis](https://www.withpower.com/clinical-trials/osteoarthritis) and rheumatoid arthritis has been previously reported." - Anonymous Online Contributor

Unverified Answer

What causes arthritis?

"The most popular theory for arthritis is that arthritis is a disease of synovial joints. There is no convincing evidence to support this notion. Many other theories have been propounded without evidence to support them. There are many other possible causes of arthritis that could contribute to both arthritis's pathogenesis and its development. Therefore, there are multiple possible causes of arthritis. The only way to distinguish among a multiplicity of hypotheses for pain in joints is to conduct a clinical study in which the hypotheses are tested against each other. The most plausible explanation of pain in joints is the view that there is a persistent inflammation of the joint that the body's natural mechanisms cannot eradicate. Whether this is by an infection or autoimmune process, it has no clear etiology." - Anonymous Online Contributor

Unverified Answer

Can arthritis be cured?

"Arthritis cannot be cured. However, advances in treatments such as anti-TNF-a therapy may result in significant improvements in joint pain compared to placebo, and therefore are highly recommended due to the high cost." - Anonymous Online Contributor

Unverified Answer

What are common treatments for arthritis?

"Common treatment for arthritis includes analgesics (such as aspirin and non-steroidal anti-inflammatories) and topical medications. Other common treatments that involve physiotherapy include compression garments and relaxation therapies. There is no evidence for a role of cognitive behavioural therapy in osteoarthritis treatment. There is good guidance on the use of exercise for people with arthritis." - Anonymous Online Contributor

Unverified Answer

What is arthritis?

"We have demonstrated that there is no difference in age between females and males with JIA. Age at disease onset, symptoms at first visit or response to treatment are also similar for females and males." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets arthritis?

"The average age someone had symptoms of [rheumatoid arthritis](https://www.withpower.com/clinical-trials/rheumatoid-arthritis) was 61 years. This can be a difficult time in a person's life. Treating and managing arthritis is important for everyone so that they can carry on with their lives as well as manage their illness, but not everyone gets diagnosed with arthritis." - Anonymous Online Contributor

Unverified Answer

Does micro-fragmented adipose tissue (mfat) improve quality of life for those with arthritis?

"MFAT is a rich source of multiple biologically active substances that may contribute to improved quality of life and is potentially a safe and viable therapeutic option for rheumatoid arthritis." - Anonymous Online Contributor

Unverified Answer

What does micro-fragmented adipose tissue (mfat) usually treat?

"The only way to determine the clinical efficacy of mfat treatment is to consider the patient’s state of readiness to be treated and the treatment plan to be selected. The treatment of mfat with an intra-articular injection of a special fat-derived solution is effective in the relief of pain associated with arthritis." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in micro-fragmented adipose tissue (mfat) for therapeutic use?

"In the study, mfat showed potential for use of a biocompatible biodegradable, non-immunogenic, lipid-based formulation which could be administrated directly into a patient without the need for a second surgical incision." - Anonymous Online Contributor

Unverified Answer

Is micro-fragmented adipose tissue (mfat) safe for people?

"Although no adverse events were reported from this study this can only be inferred from this study and other studies on mfat, both from the general population and those suffering with comorbid conditions such as diabetes or high cholesterol. People who are using anti-inflammatories, as long as on a prescription and only as prescribed should not be taken at risk of acute liver injury. Other fat-soluble nutrients must be avoided, as much as possible. Fat-soluble vitamins and minerals (notably A, D, and E) must also be considered. The safety data sheet (SDS) provides guidance by virtue of its precautionary approach to fat-soluble vitamins and minerals because it acknowledges the unpredictable nature of drug interactions." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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