OncoMatch/Clinical Trials/NCT03173937
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
Is NCT03173937 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Omidubicel (former CordIn) and Miltenyi CliniMACS(R) CD34 Reagent System for severe aplastic anemia.
Treatment: Omidubicel (former CordIn) · Miltenyi CliniMACS(R) CD34 Reagent System — 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. ...
Check if I qualifyExtracted eligibility criteria
Cancer type
Myelodysplastic Syndrome
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: immunosuppressive therapy (ATG, cyclosporine, eltrombopag)
Intolerance of or failure to respond to immunosuppressive therapy. This also includes patients who have failed immunosuppressive therapy with ATG and cyclosporine or therapy with cyclosporine combined with eltrombopag in those who are intolerant of or do not have access to treatment with ATG.
Lab requirements
Kidney function
Creatinine clearance ≥ 50 cc/min/BSAm2 by 24-hour urine collection adjusted by body surface area; Serum creatinine ≤ 2.5 mg/dl
Liver function
Transaminases ≤ 5x upper limit of normal; Serum bilirubin ≤ 4 mg/dl
Cardiac function
Left ventricular ejection fraction ≥ 40% (evaluated by ECHO)
Transaminases > 5x upper limit of normal [excluded]. Serum bilirubin >4 mg/dl [excluded]. Creatinine clearance < 50 cc/min/BSAm2 by 24-hour urine collection adjusted by body surface area [excluded]. Serum creatinine > 2.5 mg/dl [excluded]. Left ventricular ejection fraction < 40% (evaluated by ECHO) [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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