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Completed Phase 1Phase 2 Interventional

Improving Blood Stem Cell Collection and Transplant Procedures

ClinicalTrials.gov ID: NCT01517035

Public ClinicalTrials.gov record NCT01517035. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 9:11 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Peripheral Blood Stem Cell Allotransplantation for Hematological Malignancies Using Ex Vivo CD3, CD19 Depletion and CD34 Selection

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Background: \- People who have some kinds of cancer can benefit from donated bone marrow stem cells. These stem cells help produce healthy bone marrow and slow or stop the spread of abnormal cells. However, stem cells transplants do not always work. Also, they may have serious side effects that can cause illness or death. The Bone Marrow Stem Cell Transplant Program is studying methods to make stem cell transplant procedures safer and more effective. Objectives: \- To test a new procedure that may improve the success and decrease the side effects of stem cell transplants. Eligibility: * Individuals 10 to 75 years of age who have a life-threatening illness that may require a stem cell transplant. * Healthy siblings who are able to provide stem cells for transplant. Design: * Participants will be screened with a medical history, physical exam, and blood and urine tests. * Donor procedures: * Stem cell donors will start by having apheresis to donate white blood cells. * Donors will receive filgrastim shots for 5 days to help move stem cells into the blood for collection. * Donors will have another round of apheresis to donate the stem cells for transplant. * Recipient procedures: * Before the transplant, recipients will have radiation twice a day for 3 days and chemotherapy for 7 days. * After the radiation and chemotherapy, recipients will receive the stem cells provided by the donor. * After the transplant, recipients will receive the white blood cells provided by the donor. * Recipients will be monitored closely for 4 months to study the success of the transplant. They will have more followup visits at least yearly thereafter. * Recipients will have a research apheresis prior to transplant and at 3 months.

Study identification

NCT ID
NCT01517035
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Enrollment
43 participants

Conditions and interventions

Eligibility (public fields only)

Age range
2 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 12, 2012
Primary completion
Mar 28, 2017
Completion
Mar 28, 2017
Last update posted
Jul 4, 2018

2012 – 2017

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland 20892

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01517035, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 4, 2018 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01517035 live on ClinicalTrials.gov.

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