Last reviewed · How we verify
ASC secretome
ASC secretome is a Cell-free regenerative therapy Biologic drug developed by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio. It is currently in Phase 2 development.
Delivers a complex mixture of bioactive factors secreted by adipose stem cells to promote tissue repair and modulate inflammation.
-
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).
| 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 | ASC secretome |
|---|---|
| Sponsor | I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio |
| Drug class | Cell-free regenerative therapy |
| Modality | Biologic |
| Phase | Phase 2 |
Mechanism of action
ASC secretome contains multiple paracrine factors including growth factors, cytokines, chemokines, and extracellular vesicles that are naturally secreted by adipose-derived stem cells. These factors work collectively to promote tissue regeneration, angiogenesis, and immunomodulation without requiring cell transplantation.
Approved indications
Common side effects
Key clinical trials
- Study on Safety and Efficacy of Two Doses of PRS CK STORM in the Modulation of the Cytokine Storm for the Treatment of Acute Respiratory Distress Syndrome (ARDS) Caused by SARS-Cov-2, Influenza A, Influenza B and Respiratory Syncytial Virus (RSV) (PHASE1, PHASE2)
- Effects of ASC Secretome on Human Osteochondral Explants
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:
- ASC secretome CI brief — competitive landscape report
- ASC secretome updates RSS · CI watch RSS
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio portfolio CI
Frequently asked questions about ASC secretome
What is ASC secretome?
How does ASC secretome work?
Who makes ASC secretome?
What drug class is ASC secretome in?
What development phase is ASC secretome in?
Related
- Drug class: All Cell-free regenerative therapy drugs
- Manufacturer: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing