Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06608134
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Safety and Feasibility of Umbilical Cord Whartons Jelly Allograft Injections for Knee Osteoarthritis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety and Feasibility of Umbilical Cord Whartons Jelly Allograft Injections for
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Pilot Study which is randomized prospective open label dose escalation non-controlled evaluating safety and feasibility of intra-articular Whartons Jelly WJ allograft will be evaluated in patients suffering with knee osteoarthritis The participants will be randomized to one of three dosing treatment arms that will consist of one intra-articular knee injection containing either low dose medium dose or high dose WJ allograft tissue
Detailed Description:
This is a Pilot Study which is randomized prospective open label dose escalation non-controlled study in which the safety and feasibility of intra-articular Whartons Jelly WJ allograft will be evaluated in patients suffering with knee OA The participants will be randomized to one of three dosing treatment arms that will consist of one intra-articular knee injection containing either low dose medium dose or high dose WJ allograft tissue
As this is a Pilot Study primarily designed to evaluate safety no control will be used The dosing groups will consist of either 2cc WJ Allograft Low Dose 3cc WJ Allograft Medium Dose or 4cc WJ Allograft High Dose with 120 total patients randomized into the three arms equally In addition to baseline outcome instruments along with imaging and laboratory studies patients will be followed for one year for evaluation of safety pain relief and functional improvements
As this is a Pilot Study primarily designed to evaluate safety no control will be used The dosing groups will consist of either 2cc WJ Allograft Low Dose 3cc WJ Allograft Medium Dose or 4cc WJ Allograft High Dose with 120 total patients randomized into the three arms equally In addition to baseline outcome instruments along with imaging and laboratory studies patients will be followed for one year for evaluation of safety pain relief and functional improvements
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None