Ignite Creation Date:
2024-05-06 @ 3:34 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04670302
Status:
UNKNOWN
Last Update Posted:
2020-12-17
First Post:
2020-12-08
Brief Title:
Mesenchymal Stem Cells and Amniotic Membrane Composite for Supraspinatus Tendon Repair Augmentation
Sponsor:
Dr Soetomo General Hospital
Organization:
Dr Soetomo General Hospital
Study Overview
Official Title:
The Efficacy of Using Allogeneic Adipose-derived Mesenchymal Stem Cells and Human Amniotic Membrane AAdMSC-HAM Composite for Supraspinatus Tendon Repair Augmentation
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
RECRUITING
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 is a non-randomized clinical trial conducted in a single tertiary hospital which investigates the efficacy of allogeneic adipose-derived mesenchymal stem cells and human amniotic membrane AAdMSC-HAM composite for supraspinatus tendon repair augmentation
Detailed Description:
Supraspinatus tendon tear is the most common factor causing shoulder pain mainly resulting in discomfort and functional deficit in individuals over the age of 35 Supraspinatus tendon repair surgery represents one of the most widely performed types of orthopedic operation Nevertheless concerns persist regarding tendon-to-bone healing during the postoperative period Despite advancements in surgical technique re-tear of a previously repaired supraspinatus tendon is a fairly common complication especially in a larger size tear Such repair technique employing suture anchor devices alone has not yet produced functional results demonstrating both anatomical and biomechanical properties Therefore tendon tissue engineering using a combination of scaffolds cells and growth factors stimulation offers a potential solution as a biological augmentation in tendon repair
Human amniotic membrane HAM has been widely used as a natural scaffold in tissue engineering due to many of its unique properties such as providing growth factors cytokines and tissue inhibitors of metalloproteinases adequate mechanical strength and biocompatibility Whereas mesenchymal stem cells MSCs constitute one of the adult stem cells that promote replacement and repair of damaged tissue along with normal tissue turnover These MSCs are seeded to the HAM scaffolds to biologically augment tendon repair with MSCs acting as cytokinesgrowth factors to stimulate tissue repair This approach serves as the foundation to conduct the present study The investigators aim to investigate the efficacy of using allogeneic adipose-derived MSCs and human amniotic membrane AAdMSC-HAM composite for supraspinatus tendon repair augmentation
Human amniotic membrane HAM has been widely used as a natural scaffold in tissue engineering due to many of its unique properties such as providing growth factors cytokines and tissue inhibitors of metalloproteinases adequate mechanical strength and biocompatibility Whereas mesenchymal stem cells MSCs constitute one of the adult stem cells that promote replacement and repair of damaged tissue along with normal tissue turnover These MSCs are seeded to the HAM scaffolds to biologically augment tendon repair with MSCs acting as cytokinesgrowth factors to stimulate tissue repair This approach serves as the foundation to conduct the present study The investigators aim to investigate the efficacy of using allogeneic adipose-derived MSCs and human amniotic membrane AAdMSC-HAM composite for supraspinatus tendon repair augmentation
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