Investigating the Clinical Impact of a Novel Adipose Allograft Matrix on Knee Fat Pad Impingement Treatment

NCT05880888 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 2023H0043
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief Summary

This study is to assess the effect of Renuva® on fat pad regeneration in patients with Fat pad Impingement

Conditions

Fat Pad Syndrome

Keywords

Fat Pad Impingement; Adipose Allograft Matrix

Outcome Measures

Primary Outcomes (3)

• Knee MRI measurements of fat pad thickness (mm)

  Knee MRI will be taken at 6 months post injection to compare the fat pad thickness (mm) to the MRI taken prior to the injection of Renuva.

  6 Months

• Knee MRI measurements of fat pad surface area (mm2)

  Knee MRI will be taken at 6 months post injection to compare the fat pad surface area (mm2) to the MRI taken prior to the injection of Renuva.

  6 Months

• Knee MRI measurements of fat pad volume (mm3)

  Knee MRI will be taken at 6 months post injection to compare the fat pad volume to the MRI taken prior to the injection of Renuva.

  6 Months

Secondary Outcomes (6)

• Knee injury and Osteoarthritis Outcome Score (KOOS) Pain patient reported outcome questionnaire

  6 Months

• Knee injury and Osteoarthritis Outcome Score (KOOS) Symptoms patient reported outcome

  Baseline, 1 month, 3 month and 6 month

• Knee injury and Osteoarthritis Outcome Score (KOOS) Function in daily living (ADL) patient reported outcome

  Baseline, 1 month, 3 month and 6 month

• Knee injury and Osteoarthritis Outcome Score (KOOS) Function in Sport and Recreation (Sport/Rec) patient reported outcome

  Baseline, 1 month, 3 month and 6 month

• Knee injury and Osteoarthritis Outcome Score (KOOS) knee related quality of life (QOL) patient reported outcome

  Baseline, 1 month, 3 month and 6 month

Study Arms (1)

Renuva Injection

EXPERIMENTAL

Each subject will receive a single injection of up to 3ccs of Renuva into their diseased fat pad.

Biological: Renuva

Interventions

Renuva BIOLOGICAL

Renuva® (MTF Biologics) is an injectable decellularized allograft adipose matrix (AAM) used to increase volume in adipose tissue.

Renuva Injection

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Fat pad impingement
• Knee MRI taken before study enrollment
• Working knowledge of English language (to be able to complete all outcome scores)
• Ability to attend all follow-up appointments.
• Able to undergo MRI

You may not qualify if:

• Medical condition that may impact outcomes of procedure including:
• Systemic inflammatory disorders that impact the joints like rheumatoid arthritis, lupus, etc
• Undergoing current cancer treatment (other than non-melanoma skin malignancies)
• Gout, Pseudogout (including radiographic evidence of chondrocalcinosis)
• History of infection or current infection at the affected joint
• Smoking (Former smokers\< 1 year from quit date)
• Significant allergies manifested by a history of anaphylaxis or severe allergen sensitivity

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (2)

Jameson Crane Sports Medicine Institute

Columbus, Ohio, 43202, United States

Location

Ohio State Outpatient Lewis Center

Lewis Center, Ohio, 43035, United States

Location

Study Officials

• Michael Baria

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: May 30, 2023
• Study Start: April 22, 2023
• Primary Completion: January 9, 2024
• Study Completion: February 4, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)