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ASC enriched lipofilling
ASC enriched lipofilling is a Cell therapy / Regenerative medicine Biologic drug developed by Stemform. It is currently in Phase 3 development for Soft tissue augmentation and reconstruction, Lipodystrophy and contour deformities.
ASC enriched lipofilling uses adipose-derived stem cells (ASCs) combined with autologous fat to promote tissue regeneration and improve graft survival in soft tissue augmentation.
ASC enriched lipofilling is a cosmetic fat transplantation procedure that has been studied for treating breast hypoplasia and facial ageing. It involves the use of expanded adipose-derived autologous mesenchymal stromal cells enriched in fat grafts, which is a small molecule modality.
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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 | ASC enriched lipofilling |
|---|---|
| Sponsor | Stemform |
| Drug class | Cell therapy / Regenerative medicine |
| Modality | Biologic |
| Therapeutic area | Regenerative Medicine / Plastic and Reconstructive Surgery |
| Phase | Phase 3 |
Mechanism of action
The therapy enriches harvested autologous fat with adipose-derived stem cells, which are known to secrete growth factors and cytokines that enhance angiogenesis, reduce inflammation, and improve the viability and integration of transplanted adipose tissue. This cell-enriched approach aims to increase graft retention and functional outcomes compared to conventional lipofilling alone.
Approved indications
- Soft tissue augmentation and reconstruction
- Lipodystrophy and contour deformities
Common side effects
- Infection at harvest or injection site
- Hematoma or seroma
- Graft resorption
- Pain or discomfort at donor site
Key clinical trials
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 enriched lipofilling CI brief — competitive landscape report
- ASC enriched lipofilling updates RSS · CI watch RSS
- Stemform portfolio CI
Frequently asked questions about ASC enriched lipofilling
What is ASC enriched lipofilling?
How does ASC enriched lipofilling work?
What is ASC enriched lipofilling used for?
Who makes ASC enriched lipofilling?
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What development phase is ASC enriched lipofilling in?
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Related
- Drug class: All Cell therapy / Regenerative medicine drugs
- Manufacturer: Stemform — full pipeline
- Therapeutic area: All drugs in Regenerative Medicine / Plastic and Reconstructive Surgery
- Indication: Drugs for Soft tissue augmentation and reconstruction
- Indication: Drugs for Lipodystrophy and contour deformities
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing