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allogeneic stem cell transplant
allogeneic stem cell transplant is a Cell therapy Biologic drug developed by University of Wuerzburg. It is currently in Phase 3 development for Acute myeloid leukemia (AML), Acute lymphoblastic leukemia (ALL), Chronic myeloid leukemia (CML). Also known as: Allogeneic Hematopoietic Stem Cell Transplantation.
Allogeneic stem cell transplant replaces a patient's diseased or damaged bone marrow with healthy stem cells from a donor to restore normal hematopoietic and immune function.
Allogeneic stem cell transplant involves the transplantation of multipotent hematopoietic stem cells from a donor into a recipient, typically to replicate and produce normal blood cells. This procedure is used to treat various conditions, including leukemia, acute myeloid leukemia in remission, and neuroblastoma, among others.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | allogeneic stem cell transplant |
|---|---|
| Also known as | Allogeneic Hematopoietic Stem Cell Transplantation |
| Sponsor | University of Wuerzburg |
| Drug class | Cell therapy |
| Modality | Biologic |
| Therapeutic area | Oncology, Hematology, Immunology |
| Phase | Phase 3 |
Mechanism of action
The transplanted allogeneic stem cells engraft in the recipient's bone marrow and differentiate into functional blood and immune cells, reconstituting the hematopoietic system. This approach is used to treat hematologic malignancies, severe aplastic anemia, and certain genetic disorders. The donor immune cells may also provide a graft-versus-tumor (GVT) effect that helps eliminate residual malignant cells.
Approved indications
- Acute myeloid leukemia (AML)
- Acute lymphoblastic leukemia (ALL)
- Chronic myeloid leukemia (CML)
- Myelodysplastic syndrome (MDS)
- Severe aplastic anemia
- Lymphoma
Common side effects
- Graft-versus-host disease (GVHD)
- Infection
- Mucositis
- Hepatic veno-occlusive disease
- Graft failure or rejection
- Secondary malignancy
Key clinical trials
- Quality of Life in Patients Who Have Undergone Stem Cell Transplant
- Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic Leukemia (NA)
- A Nature-Based Virtual Reality (VR) Intervention in Family Caregivers of Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients (NA)
- Venetoclax or Placebo in Combination With Reduced-Intensity Conditioning Hematopoietic Cell (Bone Marrow/Blood Stem Cell) Transplant and as Maintenance Therapy After Transplant in Patients With Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial) (PHASE2)
- MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial) (PHASE2)
- Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2 (PHASE3)
- Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments (PHASE2)
- Safety and Efficacy Study of Transplantation of Autologous CD34+ Cells Transduced With the G2ARTE Lentiviral Vector Expressing the DCLRE1C cDNA in Artemis (DCLRE1C) Deficient Severe Combined Immunodeficiency Patients (ARTEGENE) (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- allogeneic stem cell transplant CI brief — competitive landscape report
- allogeneic stem cell transplant updates RSS · CI watch RSS
- University of Wuerzburg portfolio CI
Frequently asked questions about allogeneic stem cell transplant
What is allogeneic stem cell transplant?
How does allogeneic stem cell transplant work?
What is allogeneic stem cell transplant used for?
Who makes allogeneic stem cell transplant?
Is allogeneic stem cell transplant also known as anything else?
What drug class is allogeneic stem cell transplant in?
What development phase is allogeneic stem cell transplant in?
What are the side effects of allogeneic stem cell transplant?
Related
- Drug class: All Cell therapy drugs
- Manufacturer: University of Wuerzburg — full pipeline
- Therapeutic area: All drugs in Oncology, Hematology, Immunology
- Indication: Drugs for Acute myeloid leukemia (AML)
- Indication: Drugs for Acute lymphoblastic leukemia (ALL)
- Indication: Drugs for Chronic myeloid leukemia (CML)
- Also known as: Allogeneic Hematopoietic Stem Cell Transplantation
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing