National Project to Implement Mesenchymal Stem Cell for the Treatment of Perianal Crohn's Fistula (the PRIME Study) (PRIME)

January 17, 2023 updated by: Jose-M Ramirez, Universidad de Zaragoza
Darvadstrocel is an expanded allogeneic adipose-derived mesenchymal stem cell therapy for the treatment of complex perianal fistulas in patients with Crohn's disease. Safety and efficacy of the procedure has been sufficiently demonstrated and the Spanish Agency of Medication approved its application a few months ago. Being aware about the difficulties to a proper application and management of the stem cells the Spanish Stem Cell therapy group devised, in a joint activity with the Spanish Group GERM (Grupo Español de Rehabilitacion Multimodal) dedicated to expand the best surgical clinical practices, a national project for the application of the therapy. The objective is to get a homogeneous implementation in all hospitals in Spain that have being baked to use this biological therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

63

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain
        • Hospital Vall d´hebron
      • Valencia, Spain
        • Hospital La Fe
    • Alicante
      • Elche, Alicante, Spain
        • Hospital de Elche
    • Pontevedra
      • Vigo, Pontevedra, Spain
        • HOSPITAL Meixoeiro Vigo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patiens with perianal Crohn´s Disease who do not respond to current therapies.

Description

Inclusion Criteria:

  • Adults aged 18 years or older who have complex perianal Crohn fistula
  • non-active or mildly active luminal Crohn's disease for at least 6 months.
  • The fistula had to have been draining for at least 6 weeks before inclusion.

Exclusion Criteria:

• Patient with recto-vaginal fistula; rectal or anal stenosis; or active severe proctitis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Therapeutic Efficacy of Darvadstrocel-Clinical
Time Frame: 6 moths
Clinical closure of the Fistula
6 moths
Therapeutic Efficacy of Darvadstrocel-MRI
Time Frame: 6 moths
MRI imaging closure of the Fistula
6 moths

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life (QoL)
Time Frame: 6 moths
QoL according to dedicated questionnaire (EuroQoL 5D-3L)
6 moths
PATIENT REPORTED OUTCOMES (PROs)
Time Frame: 6 moths
A Dedicated self complementary questionnaire (PROMs)
6 moths
Efficiency
Time Frame: 6 moths
Cost-Effectiveness of the procedure
6 moths

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Zaragoza

Collaborators

Hospital Universitario Fundación Jiménez Díaz

Investigators

  • Principal Investigator: Jose-M Ramirez, Prof, Catedra GERM Medicina Perioperatoria
  • Study Chair: Damian Garcia-Olmo, Prof, Fundación Jiménez Diaz. Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

April 1, 2022

Study Completion (Actual)

April 30, 2022

Study Registration Dates

First Submitted

December 29, 2021

First Submitted That Met QC Criteria

January 13, 2022

First Posted (Actual)

January 27, 2022

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 17, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UZaragoza-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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