Unrelated Umbilical Cord Blood Following HLA-haploidentical Hematopoietic Stem Cell Transplantation in Patients With β-thalassemia Major

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2016-03-31

Brief Summary

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Allo-hematopoietic stem cell transplantation(HSCT) is the only way to cure β-thalassemia major at present. To expand donor pool，we developed a haplo-identical HSCT (Hi-HSCT) platform. But in prior Hi-HSCT using high dose post-transplant Cyclophosphamide in patients with leukemia, cytopenia post-transplant often developed, which was considered as a symptom of GVHD. Therefore, the investigators add unrelated umbilical cord blood (UCB) to the Hi-HSCT. It has reported that, as third-party cells, UCB will reduce GVHD.The purpose of this study is to determine whether unrelated UCB following Hi-HSCT can improve outcomes of Hi-HSCT in patients with β-thalassemia major.

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Detailed Description

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Conditions

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Thalassemia Major

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hi-HSC-CBT

Group Type OTHER

unrelated CB following haplo-identical hematopoietic stem cells transplantation

Intervention Type GENETIC

Interventions

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unrelated CB following haplo-identical hematopoietic stem cells transplantation

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* β-thalassemia major
* \< 18 year old
* Unrelated umbilical cord blood following Haplo-identical HSCT

Exclusion Criteria

* ≥ 18 year old
* HLA- matched related donors
* Unrelated donor transplants
* Unrelated umbilical cord blood transplants
* Severe iron overload in heart by T2\*

Minimum Eligible Age

12 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No