Prospective non-interventional investigation to evaluate the long-term safety and linked efficacy of the three-dimensional autologous chondrocyte implantation product in paediatric patients from 15 to less than 18 years of age treated with the product (cod16 HS17 paed)

Study identification

• EU PAS number:
  EUPAS8273
• Study ID:
  35961
• Official title and acronym:
  Prospective non-interventional investigation to evaluate the long-term safety and linked efficacy of the three-dimensional autologous chondrocyte implantation product in paediatric patients from 15 to less than 18 years of age treated with the product (cod16 HS17 paed)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  This is a company-sponsored national, open-label, multicentre, non-interventional study in a cohort of adolescent outpatients combining a retrospective data collection and current evaluation of health status by physical examination and validated patient and physician’s questionnaires.Following Directive 2006/1901 the development auf co.don chondrosphere® in paediatric population was discussed with the paediatric committee (PDCO) and a paediatric investigation plan (PIP) was developed. In the context of this PIP, the company is now gathering further safety and linked efficacy data of paediatric patients who have been treated with co.don chondrosphere®. The overall research goal is to assess the long-term safetyand linked efficacy of the three-dimensional autologous chondrocyte implantation product co.don chondrosphere® (ACI-M) in paediatric patients from 15 to less than 18 years of age at the time of implantation.
• Study status:
  Finalised

Research institutions and networks

Institutions

Dr. Ruhnau

Multiple centres: 20 centres are involved in the study, various centres across Germany, Germany

Study timelines

Date when funding contract was signed

Planned:25/08/2014

Actual:25/08/2014

Study start date

Planned:30/03/2015

Actual:27/04/2015

Data analysis start date

Planned:01/02/2016

Actual:01/02/2016

Date of interim report, if expected

Planned:30/09/2016

Actual:15/09/2016

Date of final study report

Planned:30/06/2020

Actual:18/05/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

CO.DON AG

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable