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

Fat Pad Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05880888
• Other study ID #: 2023H0043
• Status: Recruiting
• Phase: Phase 1
• Start date: April 22, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: June 2023
• Source: Ohio State University
• Contact: Michael Keller
• Phone: 614-293-2410
• Email: michael.keller[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: April 30, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Fat Pad Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Jameson Crane Sports Medicine Institute	Columbus	Ohio
United States	Ohio State Outpatient Lewis Center	Lewis Center	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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