Ignite Creation Date:
2024-05-06 @ 7:04 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05880888
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-06-26
First Post:
2023-05-10
Brief Title:
Investigating the Clinical Impact of a Novel Adipose Allograft Matrix on Knee Fat Pad Impingement Treatment
Sponsor:
Ohio State University
Organization:
Ohio State University
Study Overview
Official Title:
Investigating the Clinical Impact of a Novel Adipose Allograft Matrix on Knee Fat Pad Impingement Treatment
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None