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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

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 197 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Study description revised
    • Eligibility criteria expanded, about 1 word
  2. Eligibility criteria revisedv196
  3. Eligibility criteria shortened, about 2 wordsv195
  4. 9 versions Re-verified since Mar 28, 2026, no change to tracked fieldsv186-v194
  5. Eligibility criteria expanded, about 34 wordsv185
Show 37 earlier versionsHide 37 earlier versions
  1. 9 versions Re-verified since Aug 27, 2025, no change to tracked fieldsv176-v184
  2. Study description expanded, about 1 wordv175
  3. 5 versions Re-verified since Jun 18, 2025, no change to tracked fieldsv170-v174
  4. Study completion date: Mar 1, 2028 to Mar 1, 2032v169
  5. Primary completion date: Apr 28, 2026 to Apr 28, 2027v168
  6. Primary completion date: Apr 28, 2025 to Apr 28, 2026v167
  7. 10 versions Re-verified since Oct 10, 2024, no change to tracked fieldsv157-v166
  8. Study description revisedv156
  9. Study Status, Study Descriptionv155
  10. 3 versions Re-verified since May 25, 2024, no change to tracked fieldsv152-v154
  11. Primary completion date: Apr 28, 2024 to Apr 28, 2025v151
  12. Re-verified, no change to tracked fieldsv150
  13. Study Status, Eligibilityv149
  14. Interventions: Omidubicel (former CordIn) (Biological) to Miltenyi CliniMACS(R) CD34 Reagent System (Device), Omidubicel (former CordIn) (Biological)v148
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03173937
Lead Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)		 Severe Aplastic Anemia, Hypo-Plastic MDS, Myelodysplastic Syndrome (MDS)
Related terms Anemia, Aplastic, Myelodysplastic Syndromes
Enrollment 37 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov