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Tissue Engineering

Adipose Allograft for Hand Arthritis

Phase < 1

Recruiting

Led By Meghan McCullough, MD

Research Sponsored by Cedars-Sinai Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients greater than 18 years, with presentation to the Cedars Sinai hand clinic for joint pain of the hand carpometacarpal, interphalangeal, proximal interphalangeal, and distal interphalangeal joints (CMC, IP, PIP or DIP joints)

Be older than 18 years old

Must not have

Those who had medication or oral supplements for the previous 4 weeks that could prolong bleeding time (e.g.; Aspirin, Plavix)

Chronic obstructive pulmonary disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test the safety and effectiveness of injecting a certain material, called adipose allograft matrix (AAM), into the small joints of the hand to treat early stage osteoar

Who is the study for?

This trial is for adults over 18 with hand joint pain and confirmed osteoarthritis in specific joints (CMC, IP, PIP, DIP). It's aimed at those seeking an alternative to current treatments like autologous fat transfer.

What is being tested?

The study tests the safety and effectiveness of injecting Allograft Adipose Matrix into small hand joints affected by osteoarthritis. The goal is to see if this treatment improves pain and function without the risks of traditional methods.

What are the potential side effects?

Possible side effects may include reactions at the injection site such as pain, swelling or infection. Since it involves a local anaesthetic, there might also be temporary numbness or tingling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 and have hand joint pain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken Aspirin, Plavix, or similar drugs that could increase bleeding in the last 4 weeks.

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I have chronic obstructive pulmonary disease.

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I have a collagen vascular disease.

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I have been diagnosed with congestive heart failure.

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I have long-term kidney problems.

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I have had previous treatments like injections or surgery on my affected joint.

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I have rheumatoid arthritis or another type of inflammatory arthritis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disability Measurement

Pain scale scores

Patient satisfaction

+2 more

Secondary study objectives

Incidence of Adverse Events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Adipose Allograft Matrix (AAM)Experimental Treatment2 Interventions

Using fluoroscopic guidance (X-ray), a needle will be injected into the joint space. 1 cc of Leneva (adipose allograft matrix, MTF Biologics) will be injected into the joint.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

local anaesthetic injection

2018

Completed Phase 4

~610

0 / 8Eligibility criteria met