Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 1 study of Myelodysplastic Syndrome (MDS) and Severe Aplastic Anemia, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
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 84-participant average among 19 other Myelodysplastic Syndrome (MDS) trials with a reported enrollment target (56% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Cord engraftment
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 |
What NCT03173937 shows while recruiting
NCT03173937 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 84-participant average among 19 other Myelodysplastic Syndrome (MDS) trials with a reported enrollment target (56% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Myelodysplastic Syndrome (MDS)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03173937's enrollment target sits among peer trials
37 12th of 19 higher than 8 of 19 other Myelodysplastic Syndrome (MDS) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndrome (MDS) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
CLN-049 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
RECRUITING · Phase 1
-
Effect of Moderate Renal Impairment and Race/Ethnicity on Treosulfan Pharmacokinetics
RECRUITING · Phase 1
-
A Phase 1B/2A Trial of NADUNOLIMAB in Combination With Azacitidine (With/Without Venetoclax) in Patients With Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)
RECRUITING · Phase 1
-
CD34+ (Malignant) Stem Cell Selection for Patients Receiving Allogenic Stem Cell Transplant
ACTIVE NOT RECRUITING · Phase 1
-
Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN
ACTIVE NOT RECRUITING · Phase 1
-
Study of Oral LY3410738 in Patients With Advanced Hematologic Malignancies With IDH1 or IDH2 Mutations
ACTIVE NOT RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02800486 · 37 participants · Phase 2
Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory GBM, AA, and AOA
- NCT03295227 · 37 participants · Phase 1
Pembrolizumab in Treating Participants With Unresectable Thymoma or Thymic Cancer
- NCT03401047 · 37 participants · Early Phase 1
Study to Assess Potential Impairments in Estradiol Augmentation of Gonadotropin Secretion in Polycystic Ovary Syndrome
- NCT03935984 · 37 participants · Phase 4
Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI