Fat Pad SyndromePhase 1NCT05880888
Investigating the Clinical Impact of a Novel Adipose Allograft Matrix on Knee Fat Pad Impingement Treatment
A Phase 1 study testing Renuva in people with Fat Pad Syndrome, run by Ohio State University at 2 sites in United States.
Trial summary
This study is to assess the effect of Renuva® on fat pad regeneration in patients with Fat pad Impingement Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Fat Pad Syndrome
- What is being tested?
- Renuva
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Apr 2023to 4 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Jameson Crane Sports Medicine Institute
Columbus, Ohio, 43202
Ohio State Outpatient Lewis Center
Lewis Center, Ohio, 43035
About this study
This study is to assess the effect of Renuva® on fat pad regeneration in patients with Fat pad Impingement
Read the 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
- Being tested
- Renuva
- Keywords
- Fat Pad Impingement, Adipose Allograft Matrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RenuvaBiological
Renuva® (MTF Biologics) is an injectable decellularized allograft adipose matrix (AAM) used to increase volume in adipose tissue.
| Study group | Role | What they receive |
|---|---|---|
| Renuva Injection | Experimental | Each subject will receive a single injection of up to 3ccs of Renuva into their diseased fat pad. Receives: Biological: Renuva |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 Months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1 month, 3 month and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start22 Apr 2023
- Primary completion9 Jan 2024
- Study completion4 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fat Pad SyndromeStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Baria, Ohio State University
- Investigators
- Michael Baria, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880888
- Sponsor's protocol ID
- 2023H0043
- Status last verified
- Mar 2025
- First submitted
- 10 May 2023
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IDP will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Clinical Impact of a Novel Adipose Allograft Matrix on Knee Fat Pad Impingement Treatment
- ClinicalTrials.gov ID
- NCT05880888
- Acronym / sponsor ID
- 2023H0043
- Conditions
- Fat Pad Syndrome
- Keywords
- Fat Pad Impingement, Adipose Allograft Matrix
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 22 Apr 2023 (actual)
- Primary completion
- 9 Jan 2024 (actual)
- Study completion
- 4 Feb 2025 (actual)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renuva Injection | Experimental | Biological: RenuvaEach subject will receive a single injection of up to 3ccs of Renuva into their diseased fat pad. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- Medical condition that may impact outcomes of procedure including:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RenuvaRenuva® (MTF Biologics) is an injectable decellularized allograft adipose matrix (AAM) used to increase volume in adipose tissue. | Biological | Renuva Injection |
Primary outcome
Knee MRI measurements of fat pad thickness (mm)
Time frame: 6 Months
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.
Knee MRI measurements of fat pad surface area (mm2)
Time frame: 6 Months
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.
Knee MRI measurements of fat pad volume (mm3)
Time frame: 6 Months
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 secondary outcomes
Knee injury and Osteoarthritis Outcome Score (KOOS) Pain patient reported outcome questionnaire
Time frame: 6 Months
Knee injury and Osteoarthritis Outcome Score (KOOS) Symptoms patient reported outcome
Time frame: Baseline, 1 month, 3 month and 6 month
Knee injury and Osteoarthritis Outcome Score (KOOS) Function in daily living (ADL) patient reported outcome
Time frame: 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
Time frame: Baseline, 1 month, 3 month and 6 month
Knee injury and Osteoarthritis Outcome Score (KOOS) knee related quality of life (QOL) patient reported outcome
Time frame: Baseline, 1 month, 3 month and 6 month
Knee injury and Osteoarthritis Outcome Score (KOOS) Pain patient reported outcome
Time frame: Baseline, 1 month, 3 month and 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: No. IDP will not be shared
Related trials for Fat Pad Syndrome
Active, not recruitingPhase 2
Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome
Cushing Syndrome
RecruitingObservational study
Diagnostic Validity Ofclinical Tests for Infrapatellar Fat Pad Impingement Syndrome
Anterior Knee Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Baria principal investigator
Ohio State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Renuva in people with Fat Pad Syndrome, run by Ohio State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee MRI measurements of fat pad thickness (mm) (time frame: 6 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.