Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2025-12-24 @ 2:23 PM
NCT ID:
NCT07137559
Eligibility Criteria:
Inclusion Criteria:
* Confirmed diagnosis of chronic lower back pain due to degenerative disc disease.
* No comparable or satisfactory alternative therapy available. Unable to participate in the ongoing CELZ-201-DDT clinical trial. Informed consent provided.
Exclusion Criteria:
* Any medical condition that poses an unacceptable risk or would interfere with treatment safety or evaluation.
* Known hypersensitivity to any component of the investigational product.
How to Request Access:
* Contact the Expanded Access Coordinator to confirm eligibility and discuss feasibility.
* Complete and submit FDA Form 3926 to the appropriate FDA review division.
* Obtain IRB review (may be expedited or post-treatment for emergency use). Coordinate drug shipment and treatment schedule.
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07137559
Study Brief:
Protocol Section:
NCT07137559