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

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

Study Overview

• Status: Recruiting
• Conditions: Fat Pad Syndrome
• Intervention / Treatment: Biological: Renuva

Detailed Description

The fat pad of the knee works to stabilize the patella and releases cytokines, growth factors, and stem cells. These cytokines, growth factors, and stem cells exhibit anti-inflammatory, anabolic effects that can be recruited to heal the articular tissues of the knee and ameliorate their catabolic effects during osteoarthritis (OA).

The majority of the current treatments for fat pad impingement (FPI) and its sequelae are primarily symptom-modifying, and structure-modifying therapies both at the joint and peri-articular structures levels cannot be overemphasized.

Renuva® (MTF Biologics) is a Food and Drug Administration approved, off-the-shelf, injectable decellularized allograft adipose matrix (AAM) used to increase volume in adipose tissue. Once injected, native cell populations infiltrate the AAM, and over time, the AAM remodels into native tissue and stimulates both adipogenesis and angiogenesis within the tissue.

Our specific aim is to assess the effect of Renuva® on fat pad regeneration in patients with FPI. The investigators hypothesize that injection of Renuva® into a diseased fat pad of the knee increase the volume of the fat pad and reduce any hemorrhage, edema or fibrosis present, when pre-to post-treatment images are compared.

• Study Type: Interventional
• Enrollment (Estimated): 5
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Michael Keller; Phone Number: 614-293-2410; Email: michael.keller@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43202
      • Recruiting
      • Jameson Crane Sports Medicine Institute
      • Contact: Michael Keller; Phone Number: 614-293-2410; Email: michael.keller@osumc.edu
      • Principal Investigator: Michael Baria
    • Lewis Center, Ohio, United States, 43035
      • Recruiting
      • Ohio State Outpatient Lewis Center
      • Contact: Michael Keller; Phone Number: 614-293-2410; Email: michael.keller@osumc.edu
      • Principal Investigator: Michael Baria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18-85 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Renuva Injection; Each subject will receive a single injection of up to 3ccs of Renuva into their diseased fat pad.	Biological: Renuva; Renuva® (MTF Biologics) is an injectable decellularized allograft adipose matrix (AAM) used to increase volume in adipose tissue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee injury and Osteoarthritis Outcome Score (KOOS) Pain patient reported outcome questionnaire	KOOS Pain evaluates short-term and long-term pain in subjects with knee injury and osteoarthritis. Scores range from 0-100 where 100 represents no knee pain.	6 Months
Knee injury and Osteoarthritis Outcome Score (KOOS) Symptoms patient reported outcome	KOOS symptoms evaluates short-term and long-term symptoms in subjects with knee injury and osteoarthritis. Scores range from 0-100 where 100 represents no knee symptoms.	Baseline, 1 month, 3 month and 6 month
Knee injury and Osteoarthritis Outcome Score (KOOS) Function in daily living (ADL) patient reported outcome	KOOS ADL evaluates short-term and long-term function in daily living in subjects with knee injury and osteoarthritis. Scores range from 0-100 where 100 represents no knee related issues in regards to daily living activity.	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	KOOS Sport/Rec evaluates short-term and long-term function in sports and recreation in subjects with knee injury and osteoarthritis. Scores range from 0-100 where 100 represents no knee related issues in regards to sports or recreation activity.	Baseline, 1 month, 3 month and 6 month
Knee injury and Osteoarthritis Outcome Score (KOOS) knee related quality of life (QOL) patient reported outcome	KOOS QOL evaluates short-term and long-term knee quality of life in subjects with knee injury and osteoarthritis. Scores range from 0-100 where 100 represents no knee related issues in regards to quality of life.	Baseline, 1 month, 3 month and 6 month
Knee injury and Osteoarthritis Outcome Score (KOOS) Pain patient reported outcome	KOOS Pain evaluates short-term and long-term pain in subjects with knee injury and osteoarthritis. Scores range from 0-100 where 100 represents no knee pain.	Baseline, 1 month, 3 month and 6 month

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Michael Baria, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2023
• Primary Completion (Estimated): November 30, 2023
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: May 10, 2023
• First Submitted That Met QC Criteria: May 26, 2023
• First Posted (Actual): May 30, 2023

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 22, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Fat Pad Impingement; Adipose Allograft Matrix
• Other Study ID Numbers: 2023H0043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IDP will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes