Renuva
BiologicalRenuva® (MTF Biologics) is an injectable decellularized allograft adipose matrix (AAM) used to increase volume in adipose tissue.
NCT Number: NCT05880888
This study is to assess the effect of Renuva® on fat pad regeneration in patients with Fat pad Impingement
Looking for future studies?
Notify Me18 year–85 year
All sexes
Interventional
Phase 1
Jameson Crane Sports Medicine Institute, Columbus, Ohio, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Renuva® (MTF Biologics) is an injectable decellularized allograft adipose matrix (AAM) used to increase volume in adipose tissue.
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.
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.
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.
Time frame: 6 Months
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.
Time frame: Baseline, 1 month, 3 month and 6 month
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.
Time frame: Baseline, 1 month, 3 month and 6 month
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.
Time frame: Baseline, 1 month, 3 month and 6 month
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.
Time frame: Baseline, 1 month, 3 month and 6 month
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.
Time frame: Baseline, 1 month, 3 month and 6 month
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.
Ohio State University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04378270
Fasciitis, Fasciitis, Plantar
Pittsburgh, Pennsylvania, United States
View Trial Details