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Stem Cells From Human Exfoliated Teeth
Stem Cells From Human Exfoliated Teeth is a Biologic drug developed by CAR-T (Shanghai) Biotechnology Co., Ltd.. It is currently in Phase 1 development.
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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 | Stem Cells From Human Exfoliated Teeth |
|---|---|
| Sponsor | CAR-T (Shanghai) Biotechnology Co., Ltd. |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- The Efficacy and Safety of Pulp Regeneration Induced by SHED Polymerization (NA)
- Stem Cells From Human Exfoliated Teeth in Treatment of Type 2 Diabetes (EARLY_PHASE1)
- Safety and Efficacy of SHED for Decompensated Liver Cirrhosis (EARLY_PHASE1)
- Stem Cells From Human Exfoliated Teeth in Treatment of Diabetic Patients With Significantly Reduced Islet Function (EARLY_PHASE1)
- Revitalization of Immature Permanent Teeth With Necrotic Pulps Using SHED Cells (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:
- Stem Cells From Human Exfoliated Teeth CI brief — competitive landscape report
- Stem Cells From Human Exfoliated Teeth updates RSS · CI watch RSS
- CAR-T (Shanghai) Biotechnology Co., Ltd. portfolio CI
Frequently asked questions about Stem Cells From Human Exfoliated Teeth
What is Stem Cells From Human Exfoliated Teeth?
Who makes Stem Cells From Human Exfoliated Teeth?
What development phase is Stem Cells From Human Exfoliated Teeth in?
Related
- Manufacturer: CAR-T (Shanghai) Biotechnology Co., Ltd. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing