Adding Dilanubicel to Single-Unit Cord-Blood Transplantation Has Favorable Safety Profile

Medically reviewed by Carmen Pope, Senior Medical Editor, B. Pharm. Last updated on May 1, 2026.

via HealthDay

FRIDAY, May 1, 2026 -- Adding dilanubicel, a cryopreserved, cord blood (CB)-derived, non-human leukocyte antigen-matched expanded progenitor cell product generated from pooled donors, to single-unit cord-blood transplantation (CBT) has a favorable safety profile and excellent clinical outcomes, according to a study published online April 27 in the Journal of Clinical Oncology.

Filippo Milano, M.D., Ph.D., from the Fred Hutchinson Cancer Center in Seattle, and colleagues examined the safety of adding dilanubicel to single-unit CBT in a phase 2 study involving 28 patients with hematological malignancies. A matched single cord blood-unit infusion was followed by a target dose of 800 × 10⁶ CD34⁺ cells of dilanubicel. All patients received a myeloablative conditioning regimen and graft-versus-host disease (GVHD) prophylaxis.

The researchers found that dilanubicel induced transient myelomonocytic recovery, which peaked on day 7 and was absent by day 14. By day 9, an early lymphocyte expansion occurred, derived exclusively from the CB graft, which peaked by day 11. There was no grade 3 to 4 acute or chronic GVHD. Twenty-seven patients remained alive and disease-free at a median follow-up of 1.4 years. Patients treated with dilanubicel demonstrated faster hematopoietic recovery and had a markedly lower incidence of severe acute GVHD compared with a contemporaneous institutional cohort receiving standard single- or double-unit CBT.

"The cells from the pooled donor stem cell product did not remain long term, but they all helped the matched cord blood donor establish a new, healthy immune system in the patient," Milano said in a statement.

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Source: HealthDay

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