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Preventing Stem Cell Transplant Complications With a Blood Separator Machine
NCT01866839 · View on ClinicalTrials.gov ↗
Study Summary
Background: \- Researchers are working to make stem cell transplant procedures safer and more effective. One complication of transplants is graft-versus-host disease (GVHD). This complication happens when certain white blood cells from the donor attack the recipient's own body. Researchers want to test a blood separator machine that may help remove more of the donor's white blood cells before transplant. They will study donors and recipients during stem cell transplant to see how well this process can prevent GVHD and other complications. Objectives: \- To see if a new blood separator machine can improve outcomes of stem cell transplants. Eligibility: * Individuals between 10 and 75 years of age who are having a stem cell transplant for leukemia or other blood-related cancers. * Donors for the stem cell transplant. Design: * Recipients and donors will be screened with a physical exam and medical history. * Donors will have two blood collection procedures. The first will collect only white blood cells, and return the rest of the blood. After the first collection, participants will have filgrastim injections to help their stem cells enter their blood. Then, they will have a second blood collection for the stem cells. * Recipients will have radiation and chemotherapy to prepare for the stem cell transplant. They will then have the stem cell transplant with the donor cells that have been treated with the blood separator machine. * Recipients will be monitored closely after the procedure. They may receive some of their donor's white blood cells if needed to fight serious infections. * Recipients will have the regular standard of care after their transplant. Blood samples will be taken and any side effects will be monitored and treated.
Conditions Studied
Interventions
- DEVICE Graft Manipulation (CD34+ Selection)
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2013-05-29 |
| Est. Completion | 2018-06-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01866839
The ClinicalTrials.gov registry entry for NCT01866839 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 381 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Lymphoma, Non-Hodgkin appearing as the primary indexed condition, and to 1 intervention — of which Graft Manipulation (CD34+ Selection) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01866839 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01866839 about?
NCT01866839 is a clinical study titled "Preventing Stem Cell Transplant Complications With a Blood Separator Machine". Background: \- Researchers are working to make stem cell transplant procedures safer and more effective. One complication of transplants is graft-versus-host disease (GVHD). This complication happens when certain white blood cells from the donor attack the recipient's own body. Researchers want to ...
What is the current status of trial NCT01866839?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2013-05-29. Estimated completion is 2018-06-28.
What conditions does trial NCT01866839 study?
This clinical trial studies the following conditions: Lymphoma, Non-Hodgkin, MDS (Myelodysplastic Syndrome), Myeloproliferative Disorder, ALL (Acute B-Lymphoblastic Leukemia), AML (Acute Myelogenous Leukemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01866839?
The interventions under investigation include: Graft Manipulation (CD34+ Selection) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01866839?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 381 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01866839 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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