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

NCT ID: NCT05880888

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-22
• Study Completion Date: 2025-02-04

Brief Summary

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

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.

Conditions

Fat Pad Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Renuva Injection

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

Group Type: EXPERIMENTAL

Renuva

Intervention Type: BIOLOGICAL

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

Interventions

Renuva

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Michael Baria

Associate Professor of Physical Medicine and Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Baria

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

Jameson Crane Sports Medicine Institute

Columbus, Ohio, United States

Ohio State Outpatient Lewis Center

Lewis Center, Ohio, United States

Countries

United States

Other Identifiers

2023H0043

Identifier Type: -

Identifier Source: org_study_id