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NCT00950846 · ClinicalTrials.gov registry record · NA

Umbilical Cord Blood Transplant for Congenital Pediatric Disorders

A NA study, sponsored by Baylor College of Medicine.

Completed
Registry status
NA
Development phase
40
Enrollment target

NCT00950846 is a NA study that has completed, run by Baylor College of Medicine. The registered enrollment target is 40 participants.

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The verdict

NCT00950846, a NA study, has completed, sponsored by Baylor College of Medicine.

COMPLETED
Registry status
NA
Development phase
40 participants
Enrollment target

Study Summary

The purpose of this study is to determine the safety and effectiveness of Umbilical Cord Blood Transplant (UCBT) to treat the patient's disease, and to see if this treatment can decrease the incidence of GVHD. This study is for patients that were born with a disease that affects their body's metabolism or immune system. The doctor plans to treat the patient for this illness with a stem cell transplant. While improved medical care has allowed many people with these diseases to live longer, the only way to truly cure the diseases is by means of a stem cell transplant from a donor who does not have the disease. A stem cell transplant will replace sick cells with new healthy donor cells. Stem cells grow into different types of blood cells that people need, including red blood cells, white blood cells, and platelets. In a stem cell transplant, the patients own stem cells would be killed by chemotherapy drug and then replaced by stem cells from the donor. Stem cells can be collected from the bone marrow, peripheral blood or umbilical cords. In this study, umbilical cords will be the source of the stem cells. Currently, large inventories of umbilical cord blood units are available in public banks for transplantation in those lacking bone marrow donors. UCB transplants offer several advantages over adult bone marrow or peripheral blood stem cell transplants, including: 1. Rapid availability, 2. Absence of donor risk, 3. Low risk of transmissible infectious diseases, 4. Low risk of acute GvHD (as compared to recipients of unrelated donor marrow and peripheral blood cells). The two main causes of death after umbilical cord blood transplantation for disorders for these kinds of patients, are graft failure and infection. In this study we are trying to address these two problems by using different drugs to prepare patients for the transplant. To help improve engraftment (cells begin to grow), we will include the drug Fludarabine to the usually used Busulfan and Cytoxan th

Interventions

  • DRUG Fludarabine
  • DRUG Busulfan
  • DRUG Cytoxan
  • PROCEDURE Cord Blood Stem Cell Infusion

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2009-09
Est. Completion 2021-02-04
Phase NA

Sponsor

Baylor College of Medicine

616 total trials

What the Registry Record Tells You About NCT00950846

The ClinicalTrials.gov registry entry for NCT00950846 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Fludarabine is the first listed.

NCT00950846 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00950846 about?

NCT00950846 is a clinical study titled "Umbilical Cord Blood Transplant for Congenital Pediatric Disorders". The purpose of this study is to determine the safety and effectiveness of Umbilical Cord Blood Transplant (UCBT) to treat the patient's disease, and to see if this treatment can decrease the incidence of GVHD. This study is for patients that were born with a disease that affects their body's metabo...

What is the current status of trial NCT00950846?

This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2009-09. Estimated completion is 2021-02-04.

What interventions are being tested in trial NCT00950846?

The interventions under investigation include: Fludarabine (DRUG), Busulfan (DRUG), Cytoxan (DRUG), Cord Blood Stem Cell Infusion (PROCEDURE).

Who is sponsoring clinical trial NCT00950846?

This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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