Last reviewed · How we verify
Hearticellgram-AMI
Hearticellgram-AMI is a Cell therapy Biologic drug developed by Pharmicell Co., Ltd.. It is currently in Phase 3 development for Acute myocardial infarction with reduced left ventricular ejection fraction. Also known as: (Autologous bone marrow derived mesenchymal stem cells).
Hearticellgram-AMI is an autologous bone marrow-derived cell therapy that promotes cardiac regeneration and repair following acute myocardial infarction.
Hearticellgram-AMI is an autologous bone marrow-derived cell therapy that promotes cardiac regeneration and repair following acute myocardial infarction. Used for Acute myocardial infarction with reduced left ventricular ejection fraction.
-
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). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
| 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 | Hearticellgram-AMI |
|---|---|
| Also known as | (Autologous bone marrow derived mesenchymal stem cells) |
| Sponsor | Pharmicell Co., Ltd. |
| Drug class | Cell therapy |
| Modality | Biologic |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
The drug consists of patient's own bone marrow cells that are processed and administered to damaged myocardial tissue to stimulate neovascularization, reduce inflammation, and promote functional recovery of the heart. This cell-based approach aims to restore cardiac function by leveraging the regenerative and paracrine properties of bone marrow cells in the post-infarction setting.
Approved indications
- Acute myocardial infarction with reduced left ventricular ejection fraction
Common side effects
- Injection site reactions
- Arrhythmias
- Infection
Key clinical trials
- Long-term Follow-up Study Following the Approval of Hearticellgram-AMI Administration (NA)
- To Evaluate the Efficacy and Safety of Hearticelgram®-AMI in Patients With Acute Myocardial Infarction. (PHASE3)
- Safety Study of Clinical Cell Transplant Therapy Using Hearticellgram-AMI for Patients With Acute Myocardial Infarction
- Safety and Efficacy of Intracoronary Adult Human Mesenchymal Stem Cells After Acute Myocardial Infarction (PHASE2, PHASE3)
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:
- Hearticellgram-AMI CI brief — competitive landscape report
- Hearticellgram-AMI updates RSS · CI watch RSS
- Pharmicell Co., Ltd. portfolio CI
Frequently asked questions about Hearticellgram-AMI
What is Hearticellgram-AMI?
How does Hearticellgram-AMI work?
What is Hearticellgram-AMI used for?
Who makes Hearticellgram-AMI?
Is Hearticellgram-AMI also known as anything else?
What drug class is Hearticellgram-AMI in?
What development phase is Hearticellgram-AMI in?
What are the side effects of Hearticellgram-AMI?
Related
- Drug class: All Cell therapy drugs
- Manufacturer: Pharmicell Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Acute myocardial infarction with reduced left ventricular ejection fraction
- Also known as: (Autologous bone marrow derived mesenchymal stem cells)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing