Observational follow-up study to evaluate the long term efficacy of (HOLO-UP)

Study identification

• EU PAS number:
  EUPAS19486
• Study ID:
  25844
• Official title and acronym:
  Observational follow-up study to evaluate the long term efficacy of (HOLO-UP)
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  This is an observational, non-interventional, long-term follow-up study, where the long-term efficacy and safety of autologous cultivated limbal stem cells transplantation (ACLSCT) will be assessed in a prospective (efficacy and safety) and retrospective fashion (safety), respectively. The study will be conducted in a single site in Italy (Hospital San Raffaele, Milan) which participated as the main site (i.e. most patients treated here) in the previous retrospective HLSTM01 study.All patients who meet all the Inclusion Criteria will be contacted and invited for a follow-up visit.Each patient reached and consenting to participate will undergo to one ophtalmologic visit including pictures collection from the treated eye. The pictures will be then evaluated centrally (Independent Assessors) to provide a final and independent long-term treatment outcome.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Chiesi Farmaceutici

Study timelines

Date when funding contract was signed

Planned:01/02/2017

Actual:09/06/2017

Study start date

Planned:03/07/2017

Actual:24/08/2017

Data analysis start date

Planned:24/10/2018

Date of final study report

Planned:07/02/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Chiesi Farmaceutici SpA

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

Sponsor code: CCD-GPLSCD01-07