Regeneration of Knee and Ankle Cartilage From Autologous Cartilage Mini-grafts (From the Patient's Own Cells)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-10

Study Completion Date

2025-04-02

Brief Summary

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The purpose of this study is to investigate the safety and feasibility of implanting autologous cartilage mini-grafts (or Cartibeads) into cartilage defects in the knee and ankle.

Cartibeads are engineered from autologous articular chondrocytes (from the patient's own cartilage cells). A small cartilage biopsy (\~50 to 150 mg according to lesion size to be treated) is collected from a minimal weight bearing zone of the patient's articulation. Chondrocytes are extracted from the biopsy and expanded in culture. Our patented, standardized methodology then allows expanded cells to recover their capacity of producing hyaline matrix and to form cartilage mini-grafts (Cartibeads). These grafts are beads of 1 to 2 mm in diameter and have similar characteristics to native hyaline cartilage.

Autologous Cartibeads are implanted into the patient's cartilage defect. Patients are then followed for 12 months for assessment of study endpoints, with safety being the primary outcome.

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Detailed Description

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Conditions

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Cartilage Repair

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Autologous Cartibeads

Implantation of autologous cartilage mini-grafts (Cartibeads)

Group Type EXPERIMENTAL

Implantation of autologous cartilage mini-grafts (Cartibeads)

Intervention Type BIOLOGICAL

1. st surgery: cartilage biopsy harvest by minimally invasive surgery (arthroscopy or mini arthrotomy).
2. nd surgery: Implantation of autologous cartilage mini-grafts (Cartibeads) by minimally invasive surgery (arthroscopy or mini arthrotomy). Cartibeads should entirely fill the defect zone, followed by a thin layer of surgical glue (TISSEEL Fibrin Sealant).

Interventions

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Implantation of autologous cartilage mini-grafts (Cartibeads)

1. st surgery: cartilage biopsy harvest by minimally invasive surgery (arthroscopy or mini arthrotomy).
2. nd surgery: Implantation of autologous cartilage mini-grafts (Cartibeads) by minimally invasive surgery (arthroscopy or mini arthrotomy). Cartibeads should entirely fill the defect zone, followed by a thin layer of surgical glue (TISSEEL Fibrin Sealant).

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Cartilage focal lesion(s) ≥ 1.5 cm2 and ≤ 10 cm2
* ICRS grade 3 or 4
* Pain for 3 months or more
* Aged over 18 years

Exclusion Criteria

* Inability to undergo MRI
* Cartilage specific surgery within 12 months from baseline
* Cartilage therapeutic injection within 3 months from baseline
* Radiologically apparent degenerative joint disease (K\&L grade \>1)
* Chronic inflammatory arthritis and/or infectious arthritis

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No