Rollover Study From EXG-US-01
Part of paid clinical trials in Cincinnati, Ohio.
- Sponsor
- Elixirgen Therapeutics, Inc.
- Study ID
- NCT05868499
- Phase
- PHASE1
- Status
- Enrolling By Invitation
Conditions
- Telomere Biology Disorders With Bone Marrow Failure
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- EXG34217 — BIOLOGICALSingle infusion
Study Details
This is a long-term rollover follow-up study for Phase I/II study (Protocol EXG-US-01).
Key Dates
- Start date
- Jan 1, 2024
- Status verified
- Jul 2024
- Primary completion
- Jan 30, 2027
- Completion
- Jan 30, 2027
Study Design
- Enrollment
- 12 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: EXG34217single autologous CD34+ cells contacted ex vivo with EXG-001
Primary Outcome Measure
Number of participants with adverse events -Safety by Incidence of Treatment-Emergent [ Time Frame: Change from Baseline Systolic Blood Pressure at Month 18, 24,30,36,42,48,60 and 72 ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | - |
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