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Adipose Matrix

Renuva for Fat Pad Syndrome

Phase 1
Recruiting
Led By Michael Baria
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18-85 years of age
Ability to attend all follow-up appointments
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 month, 3 month and 6 month
Awards & highlights

Study Summary

This trial looks at how a medical treatment can help people with fat pad impingement to regrow fat pads.

Who is the study for?
This trial is for individuals aged 18-85 with Fat Pad Syndrome, specifically fat pad impingement. Participants must have had a knee MRI before joining, speak English well enough to complete surveys, and be able to attend all follow-up appointments and undergo MRIs.Check my eligibility
What is being tested?
The study is testing the effectiveness of Renuva®, an adipose allograft matrix, in regenerating the fat pad in patients' knees who are experiencing impingement.See study design
What are the potential side effects?
While specific side effects are not listed here, treatments like Renuva® could potentially cause reactions at the injection site, swelling, pain or discomfort in the knee area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 85 years old.
Select...
I can attend all required follow-up appointments.
Select...
I have been diagnosed with fat pad impingement.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 month, 3 month and 6 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month, 3 month and 6 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Knee MRI measurements of fat pad surface area (mm2)
Knee MRI measurements of fat pad thickness (mm)
Knee MRI measurements of fat pad volume (mm3)
Secondary outcome measures
Knee injury and Osteoarthritis Outcome Score (KOOS) Function in Sport and Recreation (Sport/Rec) patient reported outcome
Knee injury and Osteoarthritis Outcome Score (KOOS) Function in daily living (ADL) patient reported outcome
Knee injury and Osteoarthritis Outcome Score (KOOS) Pain patient reported outcome
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Renuva InjectionExperimental Treatment1 Intervention
Each subject will receive a single injection of up to 3ccs of Renuva into their diseased fat pad.

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
823 Previous Clinical Trials
501,238 Total Patients Enrolled
Michael BariaPrincipal InvestigatorOhio State University
1 Previous Clinical Trials
6 Total Patients Enrolled

Media Library

Renuva (Adipose Matrix) Clinical Trial Eligibility Overview. Trial Name: NCT05880888 — Phase 1
Fat Pad Syndrome Research Study Groups: Renuva Injection
Fat Pad Syndrome Clinical Trial 2023: Renuva Highlights & Side Effects. Trial Name: NCT05880888 — Phase 1
Renuva (Adipose Matrix) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05880888 — Phase 1

Frequently Asked Questions

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

Does this trial encompass geriatric individuals?

"This research is accepting participants who are aged 18 years and over, but not yet 85."

Answered by AI

Would I be allowed to participate in this research project?

"This research endeavour is recruiting up to five participants with fat pad syndrome age 18 and 85."

Answered by AI

What protective measures have been implemented to ensure the safety of those who receive Renuva Injection?

"Since Renuva Injection is still in its first phase of clinical trials, there's limited evidence to support its safety and efficacy. As a result, it was given an assessment score of 1 on our rating scale at Power."

Answered by AI

Is this research project presently seeking participants?

"Clinicaltrials.gov corroborates that this medical experiment, posted in April of 2023 and altered late May, is actively looking for participants."

Answered by AI

What is the current patient cohort participating in this experiment?

"True, clinicaltrials.gov states that this medical study is actively pursuing participants. Initially published on April 22nd of 2023 and last modified on May 26th of 2023, the trial requires 5 individuals from 2 separate research facilities to take part in it."

Answered by AI

What is the overarching purpose of this clinical experiment?

"The primary objective of this 6-month study is to examine the surface area (in millimeters squared) of fat pads in Knee MRIs. Secondary endpoints include KOOS Symptoms, which evaluates both short and long-term knee symptoms on a 0-100 scale where 100 implies no pain or discomfort; KOOS ADL, which assesses function when performing daily living activities with the same scoring system as before; and finally, KOOS Sport/Rec, an evaluation for sports or recreational activity that again uses a 0-100 rating system."

Answered by AI
~3 spots leftby Mar 2025