Last reviewed 2026-05-20 · How we verify

ChondroCelect implantation

TiGenix n.v. · Phase 3 active Small molecule ✓ Verified May 2026

ChondroCelect implantation is a Autologous cell therapy Small molecule drug developed by TiGenix n.v.. It is currently in Phase 3 development for Symptomatic cartilage defects of the knee (Grade III-IV, ICRS classification). Also known as: CCI.

ChondroCelect is an autologous cultured chondrocyte implant that replaces damaged cartilage by transplanting the patient's own expanded cartilage cells into the defect site.

ChondroCelect implantation is a treatment for articular cartilage lesions of the femoral condyle, involving the implantation of autologous cartilage cells that have been expanded ex vivo. This treatment modality falls under somatic cell supplemental therapy, where autologous cells are used to repair damaged cartilage.

Likelihood of approval

59.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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).
Immunology slight uplift +1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	ChondroCelect implantation
Also known as	CCI
Sponsor	TiGenix n.v.
Drug class	Autologous cell therapy
Modality	Small molecule
Therapeutic area	Orthopedics / Rheumatology
Phase	Phase 3

Mechanism of action

The therapy involves harvesting healthy cartilage cells from the patient's own knee, expanding them in culture over several weeks, and then implanting them back into the cartilage defect under a periosteal flap. This allows the patient's own chondrocytes to regenerate functional hyaline cartilage tissue, restoring the damaged joint surface and potentially halting or slowing osteoarthritis progression.

Approved indications

Symptomatic cartilage defects of the knee (Grade III-IV, ICRS classification)

Common side effects

Graft failure or hypertrophy
Joint effusion
Infection at biopsy or implantation site
Pain or swelling

Key clinical trials

RCT of ChondroCelect® (in an ACI Procedure) vs Microfracture in the Repair of Cartilage Defects of the Knee (PHASE3)

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:

ChondroCelect implantation CI brief — competitive landscape report
ChondroCelect implantation updates RSS · CI watch RSS
TiGenix n.v. portfolio CI

Frequently asked questions about ChondroCelect implantation

What is ChondroCelect implantation?

ChondroCelect implantation is a Autologous cell therapy drug developed by TiGenix n.v., indicated for Symptomatic cartilage defects of the knee (Grade III-IV, ICRS classification).

How does ChondroCelect implantation work?

ChondroCelect is an autologous cultured chondrocyte implant that replaces damaged cartilage by transplanting the patient's own expanded cartilage cells into the defect site.

What is ChondroCelect implantation used for?

ChondroCelect implantation is indicated for Symptomatic cartilage defects of the knee (Grade III-IV, ICRS classification).

Who makes ChondroCelect implantation?

ChondroCelect implantation is developed by TiGenix n.v. (see full TiGenix n.v. pipeline at /company/tigenix-n-v).

Is ChondroCelect implantation also known as anything else?

ChondroCelect implantation is also known as CCI.

What drug class is ChondroCelect implantation in?

ChondroCelect implantation belongs to the Autologous cell therapy class. See all Autologous cell therapy drugs at /class/autologous-cell-therapy.

What development phase is ChondroCelect implantation in?

ChondroCelect implantation is in Phase 3.

What are the side effects of ChondroCelect implantation?

Common side effects of ChondroCelect implantation include Graft failure or hypertrophy, Joint effusion, Infection at biopsy or implantation site, Pain or swelling.

Drug class: All Autologous cell therapy drugs
Manufacturer: TiGenix n.v. — full pipeline
Therapeutic area: All drugs in Orthopedics / Rheumatology
Indication: Drugs for Symptomatic cartilage defects of the knee (Grade III-IV, ICRS classification)
Also known as: CCI

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing