Ignite Creation Date:
2025-12-25 @ 12:15 AM
Ignite Modification Date:
2025-12-25 @ 10:17 PM
Study NCT ID:
NCT03461458
Status:
TERMINATED
Last Update Posted:
2022-01-25
First Post:
2018-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Autologous, Culture-Expanded Mesenchymal Stromal Cells for Degenerative Disc Disease
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
A Phase I Study Evaluating the Safety and Feasibility of Autologous, Culture-Expanded Adipose-Derived Mesenchymal Stromal Cells in Subjects With Painful Degenerative Disc Disease
Status:
TERMINATED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Principal Investigator transition
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine the safety and feasibility of autologous, culture-expanded adipose-derived (AD) mesenchymal stromal cells (MSCs) in subjects with painful degenerative disc disease (DDD).
Detailed Description:
This study is a prospective, phase I dose-escalation study evaluating the safety and feasibility of intradiscally injected AD-MSCs in the treatment of painful degenerative disc disease. The investigators propose a blended open enrollment protocol of four cohorts, each comprised of 3 subjects, to allow for interim analysis following the completion of each cohort to review safety data prior to commencing treatment of the next cohort. A total of 12 subjects will be enrolled. Subjects will be screened at outpatient clinic visit appointments and interested qualified subjects will be consented and offered participation in this trial. Once consent has been obtained baseline values will be established and subjects will begin treatment and follow-up for the next 24 months. Baseline data will include physical examination of the axial skeleton and sacroiliac region, neurologic examination, clinical assessment of low back pain and function using validated Patient Reported Outcome Measures (PROMs), radiographs, peripheral blood analysis, and MRI imaging.
Abdominal fat will be harvested through a small incision and processed by the Mayo Clinic IMPACT laboratory using current Good Manufacturing Practices (cGMPs) and previously established standard operating procedures (SOPs) to produce clinical grade, autologous, culture-expanded AD-MSCs for subsequent intradiscal injection. All injections will be performed using fluoroscopic guidance and all patients will be clinically evaluated immediately after procedure and at week 2 and 4 post-treatment to assess for acute adverse events (AEs). Following completion of their respective treatment cycle, each subject will be followed for study endpoints using a predetermined protocol, including clinical evaluation, radiography, MRI, and peripheral blood analysis. A final visit for evaluation and imaging will be conducted at the end of the study.
Abdominal fat will be harvested through a small incision and processed by the Mayo Clinic IMPACT laboratory using current Good Manufacturing Practices (cGMPs) and previously established standard operating procedures (SOPs) to produce clinical grade, autologous, culture-expanded AD-MSCs for subsequent intradiscal injection. All injections will be performed using fluoroscopic guidance and all patients will be clinically evaluated immediately after procedure and at week 2 and 4 post-treatment to assess for acute adverse events (AEs). Following completion of their respective treatment cycle, each subject will be followed for study endpoints using a predetermined protocol, including clinical evaluation, radiography, MRI, and peripheral blood analysis. A final visit for evaluation and imaging will be conducted at the end of the study.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: