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 — BIOLOGICAL
    Single 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: EXG34217
    single 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)

FacilityCityStateZIPSite coordinators
Cincinnati Children's HospitalCincinnatiOhio45229-

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