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

The Ohio State University

Status and phase

Completed

Phase 1

Conditions

Fat Pad Syndrome

Treatments

Biological: Renuva

Study type

Interventional

Funder types

Other

Identifiers

NCT05880888

2023H0043

Details and patient eligibility

About

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

Full 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.

Enrollment

3 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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