Omidubicel

OMISIRGE is a nicotinamide (NAM) modified allogeneic hematopoietic progenitor cell therapy derived from cord blood used as an allogeneic stem cell donor source. OMISIRGE is manufactured utilizing a proprietary NAM based technology producing enriched HPCs.

• OMISIRGE is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood indicated for the treatment of: adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infections. ( 1.1 ) adults and pediatric patients 6 years and older with severe aplastic anemia (SAA) following reduced intensity conditioning.ICD-10: D64.9

• OMISIRGE is contraindicated in patients with known hypersensitivity to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin, or bovine products. Known sensitivity to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin or bovine material.contraindicated

For intravenous use only. Do not irradiate. Do not use a leukodepleting filter. ( 2 ) Verify patient's identity upon receipt, prior to thaw and prior to infusion. ( 2 ) Thawing should only take place immediately prior to use. ( 2 ) Premedicate the patient approximately 30 to 60 minutes prior to infusion. ( 2 ) The recommended dose of OMISIRGE is a one-time infusion delivered in two separate bags. ( 2 ) The CF (Cultured Fraction) bag must be administered FIRST, and infusion should not exceed 2 hours from the end of dilution. Infusion of the NF (Non-cultured) bag should not exceed 1 hour from the end of dilution. ( 2 ) Administration of OMISIRGE should be under the supervision of a physician experienced in treatment of hematologic malignancies or SAA, as appropriate, in centers with expertise in hematopoietic stem cell transplants. ( 2 ) See full prescribing information for details for preparation and administration of OMISIRGE. 2.1 Dose For intravenous use only. The recommended dose of OMISIRGE is a one-time infusion delivered in two separate bags which consists of a Cultured Fraction (CF): a minimum of 8.0 × 10 8 total viable cells of which a minimum of 8.7% is CD34+ cells and a minimum of 9.2 × 10 7 CD34+ cells, and a Non-cultured Fraction (NF): a minimum of 4.0 × 10 8 total viable cells with a minimum of 2.4 × 10 7 CD3+ cells The CF and NF are supplied cryopreserved. OMISIRGE requires thaw and dilution with two infusion solution (IS) bags (one IS bag for the CF, and one IS bag for the NF) prior to administration.

Malignancies of donor origin: Monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs after treatment with OMISIRGE, contact Gamida Cell at (844) 477-7478. ( 5.5 ) Transmission of serious infections: Monitor patients closely for serious infections. ( 5.7 ) Transmission of rare genetic diseases: Monitor patients for rare genetic diseases. ( 5.8 ) 5.1 Graft-versus-Host Disease Acute and chronic graft-versus-host disease (GvHD) have occurred following treatment with OMISIRGE [see Adverse Reactions (6.1) ] . Acute GvHD manifests as maculopapular rash, gastrointestinal symptoms, and elevated bilirubin. Chronic GvHD manifests as skin rash, oral symptoms, ocular dryness, transaminase elevations, gastrointestinal symptoms, or serositis. Patients treated with OMISIRGE should receive immunosuppressive drugs to decrease the risk of GvHD, and be monitored for signs and symptoms of GvHD, and treated if GvHD develops. 5.2 Hypersensitivity and Infusion-Related Reactions Hypersensitivity and infusion-related reactions have occurred with OMISIRGE administration [see Adverse Reactions (6.1) ]. Serious hypersensitivity reactions, including anaphylaxis, may be due to DMSO, residual gentamicin, Dextran 40, human serum albumin (HSA) and bovine material in OMISIRGE. OMISIRGE may contain residual antibiotics if the cord blood donor was exposed to antibiotics in utero. Patients with a history of allergic reactions to antibiotics should be monitored for allergic reactions following OMISIRGE administration.

Hematological malignancies: The most common adverse reactions (incidence > 20%) are infections, GvHD, and infusion and hypersensitivity reactions. ( 6.1 ) SAA: The most common adverse reactions (incidence > 20%) are infections, hyperglycemia, skin rash, febrile neutropenia, immune thrombocytopenia, acute kidney injury, acute GvHD, hypertension, hypoxia, and infusion related reactions. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gamida Cell at (844) 477-7478 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Hematologic Malignancies The safety of OMISIRGE is based on data from Study P0501 for 52 patients transplanted with OMISIRGE and 56 patients transplanted with umbilical cord blood (UCB) [see Clinical Studies (14) ] . The median duration of follow up for the overall safety population was 14 months (range, 1-19 months). All patients received myeloablative preparative regimens and GvHD prophylaxis with tacrolimus or cyclosporin plus mycophenolate mofetil. Fatal adverse reactions occurred in 17% of patients treated with OMISIRGE, including infection (6%), acute GvHD (6%), veno-occlusive disease (VOD)/sinusoidal obstruction syndrome (SOS) (2%), thrombotic thrombocytopenic purpura (TTP)/thrombotic microangiopathy (TMA) (2%), and pulmonary hemorrhage (2%).

8.1 Pregnancy Risk Summary There are no available data with OMISIRGE use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with OMISIRGE to assess whether it can cause fetal harm when administered to a pregnant woman. In Study 17-H-0091, one patient reported two pregnancies, one at 9 months and one at 3.5 years post-transplant. There were no reported birth complications or neonatal concerns. OMISIRGE should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In the United States (U.S.) general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. 8.2 Lactation Risk Summary There is no information regarding the presence of OMISIRGE in human milk, the effect on the breastfed infant, and the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for OMISIRGE and any potential adverse effects on the breastfed infant from OMISIRGE or from the underlying maternal condition. 8.3 Females and Males of Reproductive Potential Pregnancy Testing Pregnancy status of females with reproductive potential should be verified.

Metabolism

OMISIRGE is a cryopreserved nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood. The nature of OMISIRGE is such that conventional pharmacokinetic studies on absorption, distribution, metabolism, and excretion are not applicable.

1. 1Acute Graft Versus Host Disease In Intestine422%
2. 2Human Herpesvirus 6 Infection422%
3. 3Septic Shock422%
4. 4Graft Versus Host Disease In Skin317%
5. 5Pyrexia317%
6. 6Acute Kidney Injury211%
7. 7Clostridium Difficile Infection211%
8. 8Drug Ineffective211%
9. 9Graft Versus Host Disease In Gastrointestinal Tract211%
10. 10Hypervolaemia211%
11. 11Intestinal Ischaemia211%
12. 12Shock211%
13. 13Transplant Failure211%
14. 14Venoocclusive Disease211%
15. 15Acute Myeloid Leukaemia Recurrent15.6%

The 5 most recently updated of 5 ClinicalTrials.gov registrations naming Omidubicel as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• 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
  Recruiting · Phase 1 · Phase 2 · Interventional · 37 enrolled · National Heart, Lung, and Blood Institute (NHLBI)
  NCT03173937updated 2026-04-06
• Stem Cell Transplantation With NiCord® (Omidubicel) vs Standard UCB in Patients With Leukemia, Lymphoma, and MDS
  Completed · Phase 3 · Interventional · 125 enrolled · Gamida Cell ltd
  NCT02730299updated 2026-02-25
• HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT
  Recruiting · Early phase 1 · Interventional · 10 enrolled · Duke University
  NCT06731504updated 2026-01-16
• Expanded Access of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies
  Completed · Phase 3 · Interventional · 36 enrolled · Gamida Cell ltd
  NCT04260698updated 2025-07-02
• Long Term Follow Up Protocol for NiCord®/CordIn™ (Omidubicel) Patients
  Completed · Observational · 33 enrolled · Gamida Cell ltd
  NCT02039557updated 2024-10-23

Frequently asked questions

How does Omidubicel work?

OMISIRGE is a nicotinamide (NAM) modified allogeneic hematopoietic progenitor cell therapy derived from cord blood used as an allogeneic stem cell donor source. OMISIRGE is manufactured utilizing a proprietary NAM based technology producing enriched HPCs.

What is Omidubicel used for?

According to FDA labeling, Omidubicel carries indications including: OMISIRGE is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood indicated for the treatment of: adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infections. ( 1.1 ) adults and pediatric patients 6 years and older with severe aplastic anemia (SAA) following reduced intensity conditioning.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What are the contraindications for Omidubicel?

Omidubicel labeling lists contraindications including: OMISIRGE is contraindicated in patients with known hypersensitivity to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin, or bovine products. Known sensitivity to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin or bovine material.. Always consult the full prescribing information and a clinician.