CELZ-201-DDT for the Treatment of Chronic Lower Back Pain
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age18-80
SponsorCreative Medical Technology Holdings Inc
About this trial
CELZ-201-DDT is an investigational (experimental) cell therapy currently being studied for people with degenerative disc disease who have chronic lower back pain.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Contact the Expanded Access Coordinator to confirm eligibility and discuss feasibility.
Complete and submit FDA Form 3926 to the appropriate FDA review division.
Trial design
Treatments tested in this trial
CELZ-201-DDT
DrugCELZ-201-DDT is administered via intramuscular injection. Dosing, administration, and follow-up will be determined by the treating physician in accordance with the EA authorization and medical judgment. Safety monitoring will be performed during and after treatment, and all serious adverse events will be reported to the FDA and IRB per applicable regulations.
Treatment groups
No treatment groups listed
Trial outcomes
This trial has no outcomes listed.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov