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NCT03173937 · ClinicalTrials.gov registry record · Phase 1
Unrelated Umbilical Cord Blood Transplantation for Severe Aplastic Anemia and Hypo-plastic MDS Using CordIn(TM), Umbilical Cord Blood-Derived Ex Vivo Expanded Stem and Progenitor Cells to Expedite Engraftment and Improve Transplant Outcome
A Phase 1 study of Myelodysplastic Syndrome (MDS) and Severe Aplastic Anemia, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
- 1
- Study location
NCT03173937 is a Phase 1 study of Myelodysplastic Syndrome (MDS) and Severe Aplastic Anemia that is actively recruiting participants, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 37 participants, below the 91-participant average among 17 other Myelodysplastic Syndrome (MDS) trials with a reported enrollment target (59% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03173937, a Phase 1 study of Myelodysplastic Syndrome (MDS) and Severe Aplastic Anemia, is actively recruiting participants, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Severe aplastic anemia (SAA) and myelodysplastic syndrome (MDS) are bone marrow diseases. People with these diseases usually need a bone marrow transplant. Researchers are testing ways to make stem cell transplant safer and more effective. Objective: To test if treating people with SAA or MDS with a co-infusion of blood stem cells from a family member and cord blood stem cells from an unrelated donor is safe and effective. Eligibility: Recipients ages 4-60 with SAA or MDS Donors ages 4-75 Design: Recipients will be screened with: * Blood, lung, and heart tests * Bone marrow biopsy * CT scan Recipients will have an IV line placed into a vein in the neck. Starting 11 days before the transplant they will have several chemotherapy infusions and 1 30-minute radiation dose. Recipients will get the donor cells through the IV line. They will stay in the hospital 3-4 weeks. After discharge, they will have visits: * First 3-4 months: 1-2 times weekly * Then every 6 months for 5 years Donors will be screened with: * Physical exam * Medical history * Blood tests Donors veins will be checked for suitability for stem cell collection. They may need an IV line to be placed in a thigh vein. Donors will get Filgrastim or biosimilar (G-CSF) injections daily for 5-7 days. On the last day, they will have apheresis: Blood drawn from one arm or leg runs through a machine and into the other arm or leg. This may be repeated 2 days or 2-4 weeks later.
Conditions Studied
Interventions
- BIOLOGICAL Omidubicel (former CordIn)
- DEVICE Miltenyi CliniMACS(R) CD34 Reagent System
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2017-06-13 |
| Est. Completion | 2032-03-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03173937
The ClinicalTrials.gov registry entry for NCT03173937 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 91-participant average among 17 other Myelodysplastic Syndrome (MDS) trials with a reported enrollment target (59% lower). 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 3 conditions, with Myelodysplastic Syndrome (MDS) appearing as the primary indexed condition, and to 2 interventions - of which Omidubicel (former CordIn) is the first listed.
NCT03173937 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT03173937 about?
NCT03173937 is a clinical study titled "Unrelated Umbilical Cord Blood Transplantation for Severe Aplastic Anemia and Hypo-plastic MDS Using CordIn(TM), Umbilical Cord Blood-Derived Ex Vivo Expanded Stem and Progenitor Cells to Expedite Engraftment and Improve Transplant Outcome". Background: Severe aplastic anemia (SAA) and myelodysplastic syndrome (MDS) are bone marrow diseases. People with these diseases usually need a bone marrow transplant. Researchers are testing ways to make stem cell transplant safer and more effective. Objective: To test if treating people with SA...
What is the current status of trial NCT03173937?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2017-06-13. Estimated completion is 2032-03-01.
What conditions does trial NCT03173937 study?
This clinical trial studies the following conditions: Myelodysplastic Syndrome (MDS), Severe Aplastic Anemia, Hypo-Plastic MDS.
What interventions are being tested in trial NCT03173937?
The interventions under investigation include: Omidubicel (former CordIn) (BIOLOGICAL), Miltenyi CliniMACS(R) CD34 Reagent System (DEVICE).
Who is sponsoring clinical trial NCT03173937?
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 NCT03173937 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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