Introduction of ACI for Cartilage Repair

NCT ID: NCT04296487

Last Updated: 2022-12-08

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2025-09-01

Brief Summary

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This study was aimed to evaluate effectiveness and safety of autologous chondrocyte suspension for treatment of knee articular cartilage defects.

Detailed Description

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* Prospective and interventional study
* All procedures are carried out after obtaining informed written consent from patients.
* Study procedures involve a biopsy, cell production, cell implantation and follow-up including a strict post-surgery rehabilitation protocol (12 month timepoint)
* All subjects will be assessed at intervals post-implantation (6 weeks, 3 months, 6 months and 12 months).
* Measures to assess effectiveness and safety will be conducted at follow-ups: Magnetic Resonance Imaging (MOCART score), collection of adverse events, orthopaedic scores (KOOS, IKDC, SF12v2)

Conditions

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Articular Cartilage Defect Chondral Defect Osteochondritis

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 Chondrocyte Injection

Autologous chondrocytes were isolated and expanded in laboratory, then injected at 2x10\^6 of cells per cm\^2 of the cartilage defect.

Group Type EXPERIMENTAL

autologous chondrocytes

Intervention Type OTHER

autologous chondrocytes implantation (ACI)

Interventions

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autologous chondrocytes

autologous chondrocytes implantation (ACI)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age between 15 and 50.
2. Lesions classified as ICRS Grade III or IV and smaller than 15 cm2
3. Lesions that have failed prior therapy (conservative or surgical treatment ≥ six months)
4. Subjects who understand and sign the consent form for this study

Exclusion Criteria

1. Body mass index (BMI) of 35 or more
2. Osteoarthritis or rheumatoid arthritis
3. Diffuse lesion
4. Uncorrected mal-alignment, ligamentous instability, or meniscal tear
5. Presence of growth cartilage (15-18 years old)
6. Active smoking or drug consumption
7. Women who are pregnant
8. Positive serology for HIV-1 or HIV-2, Hepatitis B and C and syphilis
9. Proven allergy to porcine collagen, penicillin and gentamicin
10. Poor compliance
Minimum Eligible Age

15 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role lead

Responsible Party

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Dr. Robin Martin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robin MARTIN, MD

Role: PRINCIPAL_INVESTIGATOR

CHUV

Locations

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Centre Hospitalier Universitaire Vaudois - CHUV

Lausanne, Canton of Vaud, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Robin MARTIN, MD

Role: CONTACT

021 314 76 79 ext. 41

Virginie PHILIPPE, Ph-D

Role: CONTACT

021 314 90 18 ext. 41

Facility Contacts

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Robin MARTIN, MD

Role: primary

021 314 76 79 ext. 41

Other Identifiers

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ACI-OTR

Identifier Type: -

Identifier Source: org_study_id

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