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In Utero Hematopoietic Stem Cell Transplantation for Alpha-thalassemia Major (ATM)

NCT02986698 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-01-27

No results posted yet for this study

Summary

The investigators aims to evaluate the safety of in utero hematopoietic stem cell transplantation in fetuses with alpha-thalassemia major performed at the time of in utero transfusion of red blood cells.

Conditions

  • Alpha Thalassemia Major
  • Hemoglobinopathy; with Thalassemia
  • Hemoglobinopathies
  • Fetal Anemia
  • Fetal Hydrops
  • Alpha; Thalassemia
  • Thalassemia Major
  • Thalassemia Alpha
  • A-Thalassemia

Interventions

BIOLOGICAL

in utero hematopoietic stem cell transplantation

This is a phase 1 safety study to demonstrate it is safe for both the mother and fetus to perform In utero hematopoietic stem cell transplantation of maternal derived stem cells at the time of intrauterine transplantation of red blood cells to treat fetuses affected with alpha-thalassemia major.

Sponsors & Collaborators

Principal Investigators

  • Tippi Mackenzie, MD · University of California, San Francisco

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Weeks
Max Age
26 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-05
Primary Completion
2024-04-30
Completion
2024-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02986698 on ClinicalTrials.gov