6 · Emerging therapies — cellular, gene & innovative
CALEC — cultivated autologous limbal epithelial cells (Mass Eye and Ear)
Review — modulators of corneal healing › 6 · Emerging therapies — cellular, gene & innovative › CALEC — cultivated autologous limbal epithelial cells (Mass Eye and Ear)
CALEC — cultivated autologous limbal epithelial cells (Mass Eye and Ear)
Xenobiotic/serum/antibiotic-free GMP process · U. Jurkunas · US analogue of Holoclar
Oxford II–III
Investigational (→ Moderate)
Future (USA)
Mechanism of action2 mm limbal biopsy from the healthy eye → two-step expansion (plastic culture followed by de-epithelialised amniotic membrane, 13–27 days), graft of 0.4–1.5×10⁶ cells. Restores the limbal stem cell population. Novel feature: an entirely xenobiotic/serum/antibiotic-free process (regulatory advantage).
IndicationsUnilateral LSCD with a healthy contralateral donor eye.
Route & dosageSingle surgical graft on an amniotic membrane scaffold (investigational).
Level of evidenceOxford II–III (single-arm phase I/II, small n) · Scale: Investigational but promising. Nat Commun, 4 Mar 2025 (NCT02592330): complete/partial success 93% at 12 months, 92% at 18 months; no serious AEs.
| FDA | Investigational (IND, academic trial) — not approved. |
|---|---|
| EU MA / France / Asia | Not applicable; single-centre USA. Follow-up trials (including allogeneic) planned. |
Key study: Jurkunas et al., Nature Communications 2025 — PMID 40038272 ; NCT02592330.