Six programmes. One authorised. Five in development.

Six programmes span cartilage repair, acute kidney injury, systemic inflammatory and autoimmune disease, and fibrotic conditions.

Development stage map

1. Research
2. Preclinical
3. IND-enabling
4. Pre-IND
5. CTA preparation
6. Phase 1b/2
7. Authorised (HE)

RECARTA

Hospital Exemption

RECARTA-A

Pre-IND

KELI-101

CTA preparation

KELI-102

IND-enabling

GE-MSC

Research

KELI-EXO

Preclinical

Programme development stages
Programme	Programme detail	Research	Preclinical	IND-enabling	Pre-IND	CTA preparation	Phase 1b/2	Authorised (HE)
RECARTA	Autologous chondrocyte implantationCurrent stage: Hospital Exemption	—	—	—	—	—	—	Current
RECARTA-A	Allogeneic chondrocyte platformCurrent stage: Pre-IND	—	—	—	Current
KELI-101	Acute kidney injury — post-cardiac surgeryCurrent stage: CTA preparation	—	—	—	—	Current
KELI-102	Systemic inflammatory and autoimmune diseasesCurrent stage: IND-enabling	—	—	Current
GE-MSC	Genetically engineered MSCs (CRISPR)Fibrotic and inflammatory conditionsCurrent stage: Research	Current
KELI-EXO	Placenta-derived exosomesCurrent stage: Preclinical	—	Current

Individual programme detail.

KELI-101

Acute Kidney Injury — post-cardiac surgery

CTA preparationPhase 1b/2 plannedCTA preparationFour EU countriesEIC Accelerator grant supported

Overview

KELI-101 is a placental mesenchymal stromal cell therapy in development for the prevention of acute kidney injury following cardiac surgery.

Mechanism

Paracrine immunomodulation through suppression of TNF-α, IL-6 and IFN-γ and secretion of TSG-6, PGE2, IDO and HGF.

100% survival at day 21 in hpMSC-treated rats versus 65–68% in untreated and vehicle-treated groups (p < 0.05 versus vehicle).

Serum creatinine about 3.5× lower than vehicle-treated animals at day 7 (p = 0.014); serum urea and potassium also reduced.

Gryguc A, Mačiulaitis J, et al. Int J Mol Sci 2024;25(17):9647. Rat bilateral kidney ischaemia-reperfusion model.

Opportunity

No approved therapy exists for AKI prevention in cardiac surgery. The addressable market exceeds 2 million cardiac surgeries annually in the EU and US. KELI-101 targets PRIME designation and accelerated assessment. KELI-102 will use safety data from the KELI-101 trial once available.

Current status

KELI-101: CTA in preparation, not submitted, not enrolling. First patient planned Q2 2027, subject to CTA approval. EU CTR 2026-527099-98-00

RECARTA

Autologous chondrocyte implantation — cartilage repair

Hospital ExemptionHospital ExemptionAutologous

Overview

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.

Mechanism

Patient-derived chondrocytes are harvested via arthroscopic biopsy, expanded under GMP conditions to therapeutic cell numbers, characterized for identity and viability, and re-implanted into the cartilage defect. The expanded cells integrate with native tissue and produce hyaline-like cartilage matrix, restoring joint surface integrity.

Opportunity

RECARTA's patient-specific manufacturing authorisation and clinical delivery pathway in Lithuania provide an operating foundation for cartilage therapy. Evidence collected under Hospital Exemption may inform the RECARTA-A development program, which requires its own regulatory pathway.

Current status

Manufacturing status →

RECARTA-A

Allogeneic chondrocyte implantation — off-the-shelf cartilage

Pre-INDPre-INDAllogeneicOff-the-shelf

Overview

Allogeneic, off-the-shelf chondrocyte platform. Donor-derived chondrocytes manufactured in batch lots, enabling single-stage surgery without a patient biopsy.

Mechanism

Donor-derived chondrocytes from characterized cell banks are expanded under standardized GMP conditions to produce consistent, off-the-shelf doses. Immune-privileged cartilage biology supports allogeneic use without systemic immunosuppression. Standardized release criteria ensure batch-to-batch consistency across all patient doses.

Opportunity

A single-stage allogeneic procedure would remove the biopsy and second surgery required by autologous chondrocyte implantation.

Current status

IND-enabling preclinical studies evaluating safety, immunogenicity, and efficacy in validated models. Successful completion supports regulatory submission for a first-in-human clinical trial.

KELI-102

Systemic inflammatory and autoimmune diseases

IND-enablingIND-enablingPlacental MSCIV Administration

Overview

KELI-102 targets acute and chronic systemic inflammatory and autoimmune diseases using the same intravenous placental MSC product as KELI-101. KELI-102 will use safety data from the KELI-101 trial once available.

Mechanism

Placental MSCs exert broad systemic immunomodulatory effects through paracrine signaling, T-cell suppression, regulatory macrophage polarization, and cytokine modulation. The same placental MSC product used in KELI-101 provides the biological rationale for systemic inflammatory indications.

Current status

IND-enabling. Indication prioritization for KELI-102 ongoing.

GE-MSC

Genetically engineered MSCs (CRISPR)

Research

Overview

CRISPR-engineered mesenchymal stromal cells for fibrotic and inflammatory conditions. Early research.

KELI-EXO

Placenta-derived exosomes

PreclinicalPreclinical

Programme portfolio. Six active programmes.

Six programmes span three therapeutic areas: orthopedics, nephrology, and immunology. RECARTA-A remains in development. The exosome programme remains preclinical. The programmes share manufacturing infrastructure at LUHS and process expertise, while requiring separate product authorisations.

KELI-101 is manufactured in-house at LUHS. Manufacturing status →

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