Cord for Life Completes Dosing of First Clinical Trial Using Cord Blood Stem Cells for Lower Back Pain
The Phase 1 cord blood-derived stem cell therapy for sacroiliac joint-related lower back pain showed an encouraging early safety profile and symptom improvement, supporting plans to begin Phase 2 later this year.
Key Points
- Cord for Life® has completed enrollment and dosing in a Phase 1 FDA-authorized study of an investigational cord blood-derived therapy for lower back pain linked to the sacroiliac joint.
- The company reported no unexpected adverse events to date, with preliminary observations showing reduced symptom severity scores in all nine participants within 3 to 6 months.
- The University of Florida Data Safety Monitoring Board recommended the trial continue as planned, and the company expects to submit its Phase 2 protocol to the FDA later this year.
Phase 1 Trial Update
Cord for Life® has completed enrollment and dosing in its Phase 1, evaluating an umbilical cord blood-derived stem cell therapy for lower back pain arising from the sacroiliac joint. The open-label, dose-ranging Phase 1a is under an active IND and has enrolled 9 adult subjects, with the last dose administered in early January 2026.
The company said the therapy showed a favorable early safety profile, with no unexpected adverse events reported to date. Preliminary investigator observations also suggested clinical improvement, they noted that all participants showed reductions in symptom severity scores within 3 to 6 months, with favorable trends in quality-of-life and functional-status measures.
What Comes Next
All subjects will remain in the required safety follow-up period for the next 12 months, and after the Clinical Study Report is done, they’ll begin planning the Phase 2 under the existing IND.
Phase 2 is expected to further evaluate dosing and include expanded enrollment, subject to regulatory review and completion of the required safety period.
Want to keep up on regenerative medicine? Get the weekly newsletter here.
