RECARTA
Hospital Exemption · LithuaniaAutologous chondrocyte implantation
Autologous cartilage repair therapy. Manufacturing status →
- Evidence identifier
- ATMP manufacturing permit No. 25
- Detail
- Visit recarta.eu ↗
Six programmes. Three cell platforms.
RECARTA is approved under EU Hospital Exemption in Lithuania, with product-specific ATMP manufacturing permit No. 25. The full site GMP licence is an application in progress, not granted.
Shared infrastructure. Staged development.
Programs share development infrastructure and quality systems, but authorisations remain product-specific. Manufacturing status →
RECARTA-A
Current state: Pre-IND
Allogeneic chondrocyte platform
Allogeneic, off-the-shelf chondrocyte platform. Donor-derived chondrocytes manufactured in batch lots, enabling single-stage surgery without a patient biopsy.
KELI-101
Current state: CTA preparation
Acute kidney injury — post-cardiac surgery
KELI-101: CTA in preparation, not submitted, not enrolling. First patient planned Q2 2027, subject to CTA approval. KELI-101 is manufactured in-house at LUHS. Manufacturing status →
- Evidence identifier
- EU CTR 2026-527099-98-00
- Next gate
- CTA approval
- Detail
- Programme detail →
KELI-102
Current state: IND-enabling
Systemic inflammatory and autoimmune diseases
KELI-102 will use safety data from the KELI-101 trial once available.
GE-MSC
Current state: Research
Genetically engineered MSCs (CRISPR)
Fibrotic and inflammatory conditions
CRISPR-engineered mesenchymal stromal cells for fibrotic and inflammatory conditions. Early research.
KELI-EXO
Current state: Preclinical
Placenta-derived exosomes
Placental MSC. Optimized and validated.
The KELI-100 platform utilizes highly characterized, placenta-derived mesenchymal stromal cells selected through proprietary donor screening for superior immunomodulatory potency, secretome quality, and anti-inflammatory activity. This cellular platform supports KELI-101 (AKI) and KELI-102 (Systemic inflammatory and autoimmune diseases).
Donor selection
Proprietary placental tissue screening criteria selecting for optimal MSC characteristics. Full serological, genetic, and microbiological qualification per EU Tissue and Cell Directive.
Closed-system expansion
3D suspension bioreactor culture with automated feeding, dissolved oxygen control, and real-time cell density monitoring. Zero open-vessel manipulation after initial seeding.
Potency characterization
Standardized immunomodulatory potency assay measuring T-cell suppression, pro-inflammatory cytokine modulation, and secretome anti-inflammatory activity across expansion passages.
Batch consistency
Multi-batch comparability studies confirm consistent cell identity (CD73+/CD90+/CD105+), viability (>95%), and functional potency within defined acceptance criteria.
Intellectual property
Two international patent filings (2026): PCT/EP2026/051592 and USPTO 19/632,505. Exclusive global licence from LSMU.
Screened placental tissue
Closed 3D bioreactor
Thousands of doses
Cartilage repair. Authorised and next-generation.
RECARTA-A is an allogeneic development program. Manufacturing status →
RECARTA · Hospital Exemption · Lithuania
Autologous chondrocyte implantation
Patient chondrocytes are harvested via arthroscopic biopsy, expanded under GMP conditions, and reimplanted in a second surgical procedure. Manufacturing status →
Hospital Exemption
EU Hospital Exemption · Lithuania
RECARTA-A · Pre-IND · In Development
Allogeneic chondrocyte platform
Allogeneic, off-the-shelf chondrocyte platform. Donor-derived chondrocytes manufactured in batch lots, enabling single-stage surgery without a patient biopsy.
Pre-IND
Allogeneic · Off-the-shelf
Placenta-derived exosomes
From donor screening to released therapeutic.
Platform programs can draw on common process expertise and quality systems. Manufacturing status →
Manufacturing status →
Lithuanian University of Health Sciences · Kaunas, Lithuania
Donor screening
Placental tissue qualification. Full serological, genetic, and microbiological testing per EU Tissue and Cell Directive.
Cell isolation
GMP-grade MSC or chondrocyte isolation under controlled conditions. Identity confirmation via flow cytometry panel.
Bioreactor expansion
Closed-system 3D suspension culture. Automated feeding, monitoring, and harvest at defined cell density.
Quality testing
In-process and release testing: identity, viability, potency, sterility, endotoxin, and mycoplasma per product specification.
Formulation and fill
Aseptic fill-finish in Grade A environment. Cryopreservation or fresh formulation per product specification.
Release and distribution
Full release testing panel. Cold-chain validated logistics to clinical sites across EU member states.
Technical briefing available.
Our scientific leadership presents the full platform architecture — placental MSC biology, chondrocyte programs, and early-stage pipeline — to qualified pharma BD teams, scientific evaluators, and institutional investors.