ZEMCELPRO (Dorocubicel)

ZEMCELPRO is a stem cell therapy made from a single donated umbilical cord blood unit. It received conditional marketing authorisation in the European Union on 25 August 2025 for adults with haematological malignancies (blood cancers such as acute leukaemia or myelodysplastic syndrome) who need an allogeneic stem cell transplant after myeloablative conditioning and for whom no other type of suitable donor cells is available.

It has two parts taken from the same cord blood unit. The CD34+ stem cells are expanded in the laboratory with the molecule UM171; this expanded part is dorocubicel. The remaining CD34- cells, mainly T cells, are kept unexpanded. Dorocubicel restores blood counts, while the CD34- cells help rebuild immunity and can attack leukaemia cells (graft-versus-leukaemia effect).

Ordinary cord blood units often hold too few stem cells for an adult. In the two main studies, the pivotal group of 25 adults (with acute myeloid leukaemia, acute lymphoblastic leukaemia or MDS) received small cord units expanded with this method: neutrophils recovered at a median of 20 days, and 84% had engrafted by day 42. Platelets recovered at a median of 40 days.

Unexpanded cord blood products such as Hemacord and Ducord are also used in transplants; ZEMCELPRO differs because its stem cells are multiplied before infusion.

• Given only in qualified transplant centres by doctors experienced in blood cancers, after high- or intermediate-intensity myeloablative conditioning. Conditioning starts only after the product has arrived and been checked.
• Graft-versus-host disease is common: the EU label reports acute GvHD in about 60% and chronic GvHD in about 16% of treated patients. Tacrolimus with mycophenolate mofetil is the preferred prevention.
• Serious and sometimes fatal infections, engraftment syndrome, graft failure (5.2%), bleeding in the lungs (pulmonary alveolar haemorrhage), pneumonitis and EBV-related lymphoproliferative disorder (PTLD) have been reported.
• Very low blood counts (lymphocytes, neutrophils, platelets, red cells) are expected in the weeks after infusion. Other common serious effects include febrile neutropenia, high blood pressure and low antibody levels.
• Each dose contains DMSO and a high sodium load (up to 477 mg); allergic reactions to DMSO can occur. Live vaccines are not recommended after treatment.
• It must not be used in pregnancy; a negative pregnancy test within 30 days before treatment and effective contraception are required. Treated patients must never donate blood, organs, tissues or cells.

How is a ZEMCELPRO dose made?

The transplant physician selects a matching cord blood unit (at least 4 of 6 HLA markers matched is recommended). That unit is expanded at the manufacturing site, and the finished dose is shipped frozen for that one patient. One dose is 1–4 bags of dorocubicel plus 4 bags of CD34- cells, with a small vial of the original cord blood for chimerism testing.

Can it be used in India?

ZEMCELPRO is not approved in India. Under its EU authorisation it may only be given in qualified transplant centres, so a patient in India would usually need treatment at such a centre abroad, or an early-access arrangement agreed by the manufacturer and the Indian transplant team. Outside Europe, the company has announced early-access distribution only for Argentina, Hong Kong and Singapore so far.

What documents does the transplant team need?

• Haematologist’s report of the diagnosis and disease status (for example AML, ALL or MDS in remission)
• Transplant centre’s statement that no suitable related, unrelated or haploidentical donor is available
• HLA typing of the patient
• Patient’s passport or government photo ID

How is it stored and shipped?

Frozen below −150 °C in the vapour phase of liquid nitrogen, with a shelf life of one year. Once thawed it must be infused within one hour and cannot be refrozen.

ZEMCELPRO is a made-to-order cell therapy, not a stock medicine, so supply has to be planned with the manufacturer and a qualified transplant centre before conditioning begins. IPN can share the EU product information with your transplant physician, contact the company about access options, and help organise the paperwork.

For questions about ZEMCELPRO access and cost: Call +91 96548 60915, WhatsApp +91 93100 90915 or email info@indianpharmanetwork.in.

Global Approval Status:

• European Union: Conditional marketing authorisation on 25 August 2025 (orphan medicine; PRIME scheme). Final results of the two main studies and a randomised Phase III study are still required.
• United States: Not FDA-approved as of October 2026 (orphan drug and RMAT designations; filing planned by the company).
• India: Not approved by CDSCO.

Sources:

• ZEMCELPRO – EU product information (SmPC)
• ZEMCELPRO – EMA public assessment report
• EMA news: new stem cell therapy to treat patients with blood cancers
• ExCellThera: ZEMCELPRO distribution agreement (16 July 2026)

Information last checked: October 2026.

Who is ZEMCELPRO for?

Adults with blood cancers who need a stem cell transplant after myeloablative conditioning but have no other suitable donor.

What is dorocubicel?

The part of ZEMCELPRO made of cord blood CD34+ stem cells that have been multiplied in the laboratory with UM171. It is infused first, followed by the unexpanded CD34- cells from the same cord unit.

Why expand cord blood cells?

A single cord blood unit often contains too few stem cells for an adult, which slows engraftment. Expanding them aims for faster and more reliable recovery of blood counts.

Is ZEMCELPRO fully approved in Europe?

It has a conditional approval, which means the company must submit more study data, including a randomised Phase III trial due in 2030.

Who holds the marketing authorisation?

Cordex Biologics International Limited, Dublin, Ireland. The cells are manufactured in Montreal, Canada.

Is ZEMCELPRO approved by the US FDA?

Not as of October 2026. The company has said a US filing is planned.