Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06353503
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-03-26
Brief Title:
Bone Marrow Aspirate Concentrate for Anterior Cruciate Ligament Tear Treatment
Sponsor:
abdulmajeed hammadi
Organization:
Global Stem Cell Center Baghdad
Study Overview
Official Title:
Using Autologous Bone Marrow Aspirate Concentrate to Treat Complete Anterior Cruciate Ligament Tear
Status:
RECRUITING
Status Verified Date:
2024-04
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:
A single armed multicenter study enrolling 20 patients using autologous bone marrow aspirate concentrate which is done under local or general anesthesia to aspirate around 1-2 cckg body weight then concentration which is done by using centrifugation and special disposable kit local injection of 4 cc per joint under ultrasonic guidance completely sterile field with local anesthesia
Detailed Description:
The anterior cruciate ligament ACL is key to the functional stability of the knee joint and is highly susceptible to injury especially in athletes engaged in high-impact sports Conventional treatment for partial tears may involve conservative management however complete tears often necessitate surgical reconstruction In seeking alternative treatments this study investigates the potential of bone marrow aspirate concentrate BMAC-a regenerative medicine approach-to promote healing and restore functionality to completely torn ACLs The regenerative properties of BMAC attributed to the presence of stem cells and growth factors may facilitate ligament repair and regeneration the team aim treating 1st and 2nd degree anterior cruciate ligament tear without retraction
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None