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Tissue Engineering

Adipose Allograft Matrix (AAM) for Osteoarthritis

Q: What is the current number of individuals under observation in this medical research study?

<p>Indeed, information from clinicaltrials.gov confirms the ongoing recruitment for this trial. The study was first listed on August 28th, 2023, with the most recent update made on February 5th, 2024. The research aims to enroll a total of 20 participants at one specific site.</p>

Q: Are there still available openings for new participants in this research study?

<p>As per details on clinicaltrials.gov, this research investigation is actively seeking suitable participants. The trial was initially disclosed on August 28th, 2023 and underwent its latest update on February 5th, 2024.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am over 18 and have hand joint pain.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Disability Measurement

Pain scale scores

Patient satisfaction

+2 more

Secondary outcome measures

Incidence of Adverse Events

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Musculoskeletal Transplant FoundationOTHER

20 Previous Clinical Trials

1,570 Total Patients Enrolled

2 Trials studying Osteoarthritis

54 Patients Enrolled for Osteoarthritis

Cedars-Sinai Medical CenterLead Sponsor

500 Previous Clinical Trials

164,843 Total Patients Enrolled

1 Trials studying Osteoarthritis

30 Patients Enrolled for Osteoarthritis

Meghan McCullough, MDPrincipal InvestigatorCedars-Sinai Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals under observation in this medical research study?

"Indeed, information from clinicaltrials.gov confirms the ongoing recruitment for this trial. The study was first listed on August 28th, 2023, with the most recent update made on February 5th, 2024. The research aims to enroll a total of 20 participants at one specific site."

Answered by AI

Are there still available openings for new participants in this research study?

"As per details on clinicaltrials.gov, this research investigation is actively seeking suitable participants. The trial was initially disclosed on August 28th, 2023 and underwent its latest update on February 5th, 2024."

Answered by AI

Recent research and studies

The Journal of Hand SurgeryJournal

Hylan Versus Corticosteroid Versus Placebo for Treatment of Basal Joint Arthritis: A Prospective, Randomized, Double-blinded Clinical Trial

Heyworth, Benton E., Jonathan H. Lee, Paul D. Kim, Carter B. Lipton, Robert J. Strauch, and Melvin P. Rosenwasser. 2008. “Hylan Versus Corticosteroid Versus Placebo for Treatment of Basal Joint Arthritis: A Prospective, Randomized, Double-blinded Clinical Trial”. The Journal of Hand Surgery. Elsevier BV. doi:10.1016/j.jhsa.2007.10.009.

clinicaltrials.govStudy

Use of Allograft Adipose Matrix for Small Joint Arthritis of the Hand

Meghan McCullough, MD 2023. "Use of Allograft Adipose Matrix for Small Joint Arthritis of the Hand". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05747469.