RECARTA
Hospital Exemption · LithuaniaAutologous chondrocyte implantation
RECARTA — Autologous chondrocyte implantation.
- Evidence identifier
- ATMP manufacturing permit No. 25
- Detail
- Visit recarta.eu ↗
Cell therapies for cartilage repair and acute kidney injury, manufactured in-house under EU authorisation.
KELI develops autologous and allogeneic chondrocyte products and a placental MSC therapy from one licensed ATMP manufacturing site at LUHS, with regulatory strategy led by former EMA committee members.
- RECARTA — approved under Hospital Exemption, Lithuania; permit No. 25.
- KELI-101 — CTA in preparation, not submitted, not enrolling; first patient planned Q2 2027, subject to CTA approval.
- GMP site licence — application in progress.
€3.5M
EU and national grant funding awarded to KELI
Phase 1b/2
Planned trial
1 authorised product
4 in development
2 international patent filings
PCT/EP and USPTO, 2026
2026-527099-98-00
EU clinical trial number
Three programs. Two therapeutic areas.
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
Multicenter, randomized, placebo-controlled, adaptive Phase 1b/2 trial. EU CTR: 2026-527099-98-00. Up to 142 participants across 4 EU countries. KELI-101 is manufactured in-house at LUHS.
- Evidence identifier
- EU CTR 2026-527099-98-00
- Next gate
- CTA approval
- Detail
- Programme detail →
5
Programmes
LUHS, Kaunas
Location
Chondrocytes
Platform
Placental MSC
Platform
Grade A–D
Cleanroom
RECARTA
Product
Active programs and future pipeline.
Program
Indication
Area
Stage
Progress
RECARTA
Autologous chondrocyte implantation
Orthopedics
Hospital Exemption
KELI-101
MSC therapy · AKI post-cardiac surgery
Nephrology
Phase 1b/2 planned
RECARTA-A
Allogeneic chondrocyte platform
Orthopedics
Pre-IND · In Development
KELI-102
Placental MSC · Systemic inflammatory diseases
Immunology
IND-enabling
KELI-EXO
Placenta-derived exosomes
—
Preclinical
Structured collaboration. Defined models.
KELI partners with pharmaceutical companies for co-development and licensing and with hospitals for clinical delivery in Lithuania. Gulf and Asia-Pacific market entry is planned.
Explore Partnership ModelsPharma Co-Development
AKI · Allogeneic cartilage
Exosome Development
Placenta-derived exosomes · preclinical
Hospital Networks
RECARTA HE · Clinical sites
EU Institutional
EIC · Structural Funds
Gulf region
Market entry planned
Asia-Pacific
Market entry planned
Authorised product, owned manufacturing, grant-funded base.
€3.5M in EU and national grant funding awarded to KELI, including a €2.5M EIC Accelerator grant (2025). €4.0M convertible loan (€3.9M primary, €0.1M founder secondary).
Product authorisation
Manufacturing moat
Shared manufacturing infrastructure at LUHS.
Staged risk
Five programmes with product-specific authorisations and staged development.
2025
EIC grant secured · €2.5M
2026
KELI-101 manufactured in-house at LUHS
Next gate
CTA approval
Future
Clinical readout and regulatory steps depend on trial progress
Ready for
diligence.
Keli Therapeutics is actively evaluating institutional capital, pharma co-development partnerships, and strategic collaborations. Our data room, manufacturing documentation, and clinical protocols are available for qualified parties.