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NCT01174108 · ClinicalTrials.gov registry record · Phase 2
Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells
A Phase 2 study of Severe Aplastic Anemia and MDS (Myelodysplastic Syndrome), sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 2
- Study locations
NCT01174108 is a Phase 2 study of Severe Aplastic Anemia and MDS (Myelodysplastic Syndrome) that is actively recruiting participants, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 120 participants, roughly in line with the 119-participant average among 16 other Severe Aplastic Anemia trials with a reported enrollment target. The trial reports 2 study locations across 1 state.
The verdict
NCT01174108, a Phase 2 study of Severe Aplastic Anemia and MDS (Myelodysplastic Syndrome), is actively recruiting participants, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 2
- Study locations
Study Summary
Background: * Stem cell transplants from related donors (allogenic stem cell transplants) can be used to treat individuals with certain kinds of severe blood diseases or cancers, such as severe anemia. Allogenic stem cell transplants encourage the growth of new bone marrow to replace that of the recipient. Because stem cell transplants can have serious complications, researchers are interested in developing new approaches to stem cell transplants that will reduce the likelihood of these complications. * By reducing the number of white blood cells included in the blood taken during the stem cell collection process, and replacing them with a smaller amount of white blood cells collected prior to stem cell donation, the stem cell transplant may be less likely to cause severe complications for the recipient. Researchers are investigating whether altering the stem cell transplant donation procedure in this manner will improve the likelihood of a successful stem cell transplant with fewer complications. Objectives: \- To evaluate a new method of stem cell transplantation that may reduce the possibly of severe side effects or transplant rejection in the recipient. Eligibility: * Recipient: Individuals between 4 and 80 years of age who have been diagnosed with a blood disease that can be treated with allogenic stem cell transplants. * Donor: Individuals between 4 and 80 years of age who are related to the recipient and are eligible to donate blood. OR unrelated donors found through the National Marrow Donor Program. Design: * All participants will be screened with a physical examination and medical history. * DONORS: * Donors will undergo an initial apheresis procedure to donate white blood cells. * After the initial donation, donors will receive injections of filgrastim to release bone marrow cells into the blood. * After 5 days of filgrastim injections, donors will have apheresis again to donate stem cells that are present in the blood. * RECIPIENTS: * Recipients w
Conditions Studied
Interventions
- DEVICE Miltenyi CD34 Reagent System
- OTHER Donor derived G-CSF mobilized PBC
Study Locations (2)
Maryland
- University of Maryland, Baltimore (UMB) - Baltimore
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2010-12-10 |
| Est. Completion | 2028-06-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01174108
The ClinicalTrials.gov registry entry for NCT01174108 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 119-participant average among 16 other Severe Aplastic Anemia trials with a reported enrollment target. The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Severe Aplastic Anemia appearing as the primary indexed condition, and to 2 interventions - of which Miltenyi CD34 Reagent System is the first listed.
NCT01174108 reports 2 study locations spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT01174108 about?
NCT01174108 is a clinical study titled "Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells". Background: * Stem cell transplants from related donors (allogenic stem cell transplants) can be used to treat individuals with certain kinds of severe blood diseases or cancers, such as severe anemia. Allogenic stem cell transplants encourage the growth of new bone marrow to replace that of the re...
What is the current status of trial NCT01174108?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2010-12-10. Estimated completion is 2028-06-30.
What conditions does trial NCT01174108 study?
This clinical trial studies the following conditions: Severe Aplastic Anemia, MDS (Myelodysplastic Syndrome).
What interventions are being tested in trial NCT01174108?
The interventions under investigation include: Miltenyi CD34 Reagent System (DEVICE), Donor derived G-CSF mobilized PBC (OTHER).
Who is sponsoring clinical trial NCT01174108?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01174108 being conducted?
This trial has 2 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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