NCT01605201

Brief Summary

The purpose of this study is to investigate the safety and feasibility of implanting an engineered cartilage graft obtained by culturing expanded autologous nasal chondrocytes within a collagen type I/III membrane into the cartilage defect on the femoral condyle and/or trochlea of the knee after a traumatic injury.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2012

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

August 29, 2012

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2018

Completed
Last Updated

August 27, 2018

Status Verified

August 1, 2018

Enrollment Period

6 years

First QC Date

May 22, 2012

Last Update Submit

August 23, 2018

Conditions

Cartilage LesionDegenerative Lesion of Articular Cartilage of Knee

Keywords

Chondral lesions in the knee after traumatic injury

Outcome Measures

Primary Outcomes (2)

  • 1-Safety for the patient

    Safety will be assessed by the incidence of adverse reactions and adverse events. Expected postoperative complications also occurring in the standard procedure are: pain, swelling and hematoma, casually post-anesthetic nausea, vomiting or fever.

    until 24 months

  • 2- Stability of the graft

    It will be assessed by Magnetic Resonance Imaging (MRI) technique at 6, 12 and 24 months indicating if the graft is in place and if there are signs of complications. Parameters to be evaluated are: filling of the defect, integration of the border zone to the adjacent cartilage, intactness of the subchondral lamina, intactness of the subchondral bone, and relative signal intensities of the repair tissue compared to the adjacent native cartilage.

    until 24 months

Secondary Outcomes (1)

  • Subjective pain relief

    until 24 months

Study Arms (1)

Implantation of cartilage graft

EXPERIMENTAL
Biological: Tissue engineered cartilage graft

Interventions

Tissue engineered cartilage graftBIOLOGICAL

Autologous nasal chondrocytes expanded in vitro and cultured in a collagen type I//III scaffold

Implantation of cartilage graft

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Size of the defect on the femoral cartilage:one or two symptomatic lesion(s) grade III-IV from 2 cm2 to 8 cm2 at the femoral condyle and/or trochlea
  • Other:
  • Age: 18-55 years
  • Written informed consent by the patient

You may not qualify if:

  • Defect:
  • Lesions smaller than 2cm2 or greater than 8cm2
  • Total area of all lesions bigger than 8cm2
  • Lesions other than on the femoral condyle and/or trochlea
  • Any evidence of the following diseases in the target joint: septic arthritis; inflammatory joint disease; gout; recurrent episodes of pseudogout; Paget disease of bone; ochronosis; acromegaly; hemochromatosis;Wilson disease; primary osteochondromatosis; heritable disorders; collagen gene mutations
  • Presence of a clinically relevant cartilage lesion on the patella (second lesion)
  • Patellofemoral cartilage lesion
  • Presence of relevant complex knee injuries affecting bone and/or ligaments
  • Osteochondritis dissecans: recent (within 1 year before baseline); depth of lesion \>0.5 cm; subchondral sclerosis
  • Advanced osteoarthritis (as defined by Radiographic Atlas of Osteoarthritis, grade 2-3)
  • Varus or valgus malalignment exceeding 5° (kissing lesions out)
  • Medical history:
  • gravidity (Pregnancy)
  • breast feeding
  • presence of multiple severe allergies (including porcine collagen, streptomycin and penicillin)
  • +25 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (1)

  • Mumme M, Barbero A, Miot S, Wixmerten A, Feliciano S, Wolf F, Asnaghi AM, Baumhoer D, Bieri O, Kretzschmar M, Pagenstert G, Haug M, Schaefer DJ, Martin I, Jakob M. Nasal chondrocyte-based engineered autologous cartilage tissue for repair of articular cartilage defects: an observational first-in-human trial. Lancet. 2016 Oct 22;388(10055):1985-1994. doi: 10.1016/S0140-6736(16)31658-0.

    PMID: 27789021DERIVED

Study Officials

  • Marcel Jakob, Prof. Dr.

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2012

First Posted

May 24, 2012

Study Start

August 29, 2012

Primary Completion

August 15, 2018

Study Completion

August 15, 2018

Last Updated

August 27, 2018

Record last verified: 2018-08

Locations

CH(1)