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Mesenchymal stem cells mid-dose group
Mesenchymal stem cells mid-dose group is a Biologic drug developed by Shanghai AbelZeta Ltd.. It is currently in Phase 1 development. Also known as: Adipose tissue derived mesenchymal stem cells.
Mesenchymal stem cells, specifically human umbilical cord-derived mesenchymal stem cells (hUC-MSCs), are being studied in clinical trials for various conditions including Charcot Marie Tooth Disease, Osteoarthritis, and Acute-On-Chronic Liver Failure. The mechanism of action of hUC-MSCs is classified as somatic cell supplemental therapy, which involves supplementing the body with cells to support or replace damaged or diseased cells.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Mesenchymal stem cells mid-dose group |
|---|---|
| Also known as | Adipose tissue derived mesenchymal stem cells |
| Sponsor | Shanghai AbelZeta Ltd. |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Use of hUC-MSC Product (BX-U001) for the Treatment of COVID-19 With ARDS (PHASE1, PHASE2)
- hUC-MSC-Exo Therapy for Autoimmune Encephalitis (PHASE1, PHASE2)
- The Safety and Tolerability of CLZ-2002 in Patients With Charcot-Marie Tooth Disease. (PHASE1)
- Clinical Trial to Evaluate Efficacy and Safety of SMUP-IA-01 in Patients With Knee Osteoarthritis (PHASE2)
- Outcomes of Adipose Derived Mesenchymal Stem Cells on Sexual Hormone Deficiency (PHASE1, PHASE2)
- Safety of UC-MSC Transfusion for ACLF Patients (PHASE2)
- Clinical Plan of Ischemic Stroke (PHASE1, PHASE2)
- the Safety and the Efficacy Evaluation of Allogenic Adipose MSC-Exos in Patients With Alzheimer's Disease (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:
- Mesenchymal stem cells mid-dose group CI brief — competitive landscape report
- Mesenchymal stem cells mid-dose group updates RSS · CI watch RSS
- Shanghai AbelZeta Ltd. portfolio CI
Frequently asked questions about Mesenchymal stem cells mid-dose group
What is Mesenchymal stem cells mid-dose group?
Who makes Mesenchymal stem cells mid-dose group?
Is Mesenchymal stem cells mid-dose group also known as anything else?
What development phase is Mesenchymal stem cells mid-dose group in?
Related
- Manufacturer: Shanghai AbelZeta Ltd. — full pipeline
- Also known as: Adipose tissue derived mesenchymal stem cells
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing