Last reviewed · How we verify
Cartistem
Cartistem is a Biologic drug developed by Samsung Medical Center. It is currently in Phase 3 development. Also known as: hUCB-MSCs, human umbilical cord blood-derived mesenchymal stem cells.
-
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).
| 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 | Cartistem |
|---|---|
| Also known as | hUCB-MSCs, human umbilical cord blood-derived mesenchymal stem cells |
| Sponsor | Samsung Medical Center |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
- JOINT RANGE OF MOTION DECREASED
- arthralgia
- muscle atrophy
- joint effusion
- joint swelling
- prehypertension
- joint crepitation
- bone marrow oedema
- sinusitis
- procedural pain
- soft tissue injury
- blood creatine phosphokinase increased
Key clinical trials
- Phase 3 Pivotal Trial Comparing CARTISTEM® and Surgical Comparator for Knee Cartilage Lesions and Osteoarthritis (PHASE3)
- Evaluation of Safety and Exploratory Efficacy of CARTISTEM®, a Cell Therapy Product for Articular Cartilage Defects (PHASE1, PHASE2)
- Efficacy and Safety of Allogenic Stem Cell Product(CARTISTEM®) for Osteochondral Lesion of Talus (PHASE3)
- Development of Novel Strategy for Treatment of Anterior Cruciate Ligament (ACL) Injury Using Stem Cell (NA)
- Study to Compare Efficacy and Safety of Cartistem and Microfracture in Patients With Knee Articular Cartilage Injury (PHASE3)
- Follow-Up Study of CARTISTEM® Versus Microfracture for the Treatment of Knee Articular Cartilage Injury or Defect (PHASE3)
- Safety and Efficacy of Allogenic Umbilical Cord Blood-derived Mesenchymal Stem Cell Product (EARLY_PHASE1)
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:
- Cartistem CI brief — competitive landscape report
- Cartistem updates RSS · CI watch RSS
- Samsung Medical Center portfolio CI
Frequently asked questions about Cartistem
What is Cartistem?
Who makes Cartistem?
Is Cartistem also known as anything else?
What development phase is Cartistem in?
What are the side effects of Cartistem?
Related
- Manufacturer: Samsung Medical Center — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: hUCB-MSCs, human umbilical cord blood-derived mesenchymal stem cells
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing