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Allogeneic Mesenchymal Stem Cells
Allogeneic Mesenchymal Stem Cells is a Biologic drug developed by Stempeutics Research Pvt Ltd. It is currently in Phase 2 development for Treatment of graft-versus-host disease. Also known as: Stempeucel - CLI.
Allogeneic Mesenchymal Stem Cells are thought to exert immunomodulatory effects through the release of anti-inflammatory cytokines and growth factors.
Allogeneic Mesenchymal Stem Cells are thought to exert immunomodulatory effects through the release of anti-inflammatory cytokines and growth factors. Used for Treatment of graft-versus-host disease.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 Mesenchymal Stem Cells |
|---|---|
| Also known as | Stempeucel - CLI |
| Sponsor | Stempeutics Research Pvt Ltd |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 2 |
Mechanism of action
This mechanism is believed to promote tissue repair and modulate the immune response, potentially leading to therapeutic benefits in various conditions. The exact mechanisms of action are not fully understood and may involve multiple pathways. Further research is needed to fully elucidate the effects of Allogeneic Mesenchymal Stem Cells on the body.
Approved indications
- Treatment of graft-versus-host disease
Common side effects
- Infusion-related reactions
- Infection
- Tumor lysis syndrome
Key clinical trials
- Phase 1 Study of VELGRAFT, a Living Cellular Construct, in the Management of Chronic Diabetic Foot Ulcers Which Have Attained Granulation Tissue (PHASE1)
- Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments (PHASE2)
- Administration of Allogeneic-MSC in Patients With Non-Ischemic Dilated Cardiomyopathy (PHASE2)
- Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure (PHASE3)
- Stem Cells for Erectile Dysfunction Post RALP (PHASE1, PHASE2)
- "An Intermediate Size Patient Population Expanded Access Protocol to Evaluate the Safety and Efficacy of Allogeneic HB-adMSCs (Hope Biosciences - Adipose Derived Mesenchymal Stem Cells) for the Treatment of Multiple System Atrophy."
- MSC-DNX-2401 in Treating Patients With Recurrent High-Grade Glioma (PHASE1)
- Allogeneic Human Mesenchymal Stem Cell Infusion for Frailty Patient (NA)
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 Mesenchymal Stem Cells CI brief — competitive landscape report
- Allogeneic Mesenchymal Stem Cells updates RSS · CI watch RSS
- Stempeutics Research Pvt Ltd portfolio CI
Frequently asked questions about Allogeneic Mesenchymal Stem Cells
What is Allogeneic Mesenchymal Stem Cells?
How does Allogeneic Mesenchymal Stem Cells work?
What is Allogeneic Mesenchymal Stem Cells used for?
Who makes Allogeneic Mesenchymal Stem Cells?
Is Allogeneic Mesenchymal Stem Cells also known as anything else?
What development phase is Allogeneic Mesenchymal Stem Cells in?
What are the side effects of Allogeneic Mesenchymal Stem Cells?
Related
- Manufacturer: Stempeutics Research Pvt Ltd — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Treatment of graft-versus-host disease
- Also known as: Stempeucel - CLI
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing