Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06361485
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-03-25
Brief Title:
Safety and Feasibility of Umbilical Cord Whartons Jelly Allograft Injections for Lumbar Pain
Sponsor:
R3 Stem Cell
Organization:
R3 Stem Cell
Study Overview
Official Title:
Safety and Feasibility of Umbilical Cord Whartons Jelly Allograft Injections for Lumbar Pain
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:
This is a Pilot Study that is an open label prospective non-controlled study in which the safety and feasibility of Whartons Jelly WJ allograft will be evaluated in 100 participants suffering with low back pain
Detailed Description:
This is a prospective open label non-controlled Pilot study in which the safety and feasibility of umbilical cord Whartons Jelly WJ allograft will be evaluated in participants suffering with lumbar pain The participants will receive a series of lumbar injections described in the protocol
As this is a Pilot study primarily designed to evaluate safety no control will be used The dosing will consist of 10cc WJ Allograft with 100 total participants In addition to baseline outcome instruments along with imaging and laboratory studies participants 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 will consist of 10cc WJ Allograft with 100 total participants In addition to baseline outcome instruments along with imaging and laboratory studies participants 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?:
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