Rollover Study From EXG-US-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2027-01-30

Brief Summary

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This is a long-term rollover follow-up study for Phase I/II study (Protocol EXG-US-01).

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Detailed Description

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Patients who received EXG34217 treatment and had at least one follow-up visit (Month 1, 3, 6, or 12) in Study EXG-US-01 will be eligible for this rollover study. Patient will sign a consent form prior to any study related procedure. This study is to add additional follow-up assessments up to 6 years after EXG34217 treatment. This study does not have additional intervention. Additional visits will be every 6 months in the first 3 years and once a year for two years.

Conditions

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Telomere Biology Disorders With Bone Marrow Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Sequential Assignment

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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EXG34217

single autologous CD34+ cells contacted ex vivo with EXG-001

Group Type EXPERIMENTAL

EXG34217

Intervention Type BIOLOGICAL

Single infusion

Interventions

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EXG34217

Single infusion

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Signed an Institutional Review Board (IRB) approved informed consent document indicating that they understand the purpose of, and procedures required by the study and are willing to participate in the study and comply with all study procedures and restrictions. Informed consent must be obtained from the subject prior to initiating procedures.
2. Have completed the 12-month visit of Study EXG-US-01.