Creation of a Bank of Fibroblast From Patients With Amyotrophic Lateral Sclerosis: Pilot Study (ALSCELL)

April 27, 2018 updated by: Institut Pasteur

Patients with ALS will be included in the reference center for ALS in hospital La Pitié Salpêtrière, Paris.

The study proposes to investigate the pathophysiology of ALS by setting up a fibroblast bank for studying molecular, cellular and genetic parameters of the pathology.

iPS (induced pluripotent stem cells) and then differentiated cells will be generated.

The pathophysiology of ALS will be studied on the 3 types of cells (fibroblasts, iPS, differentiated cells).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • France
      • Paris, France, 75013
        • Centre référent maladies rares SLA

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients over 18 years old
  • ALS sporadic or familial or unknown

Exclusion Criteria:

  • known cutaneous disease not allowing the biopsy
  • platelets less than 10 000/m3
  • suspected or known xylocain allergy

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

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patients
Procedure: skin biopsy
biopsy 5mm maximum on healthy skin under local anaesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Success of fibroblast culture, amplification, and freezing pellets
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Induced pluripotent Stem Cells generation success
Time Frame: 2 years
2 years
neurones, motoneurones, glial cells obtention from fibroblasts or iPS
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

Institut Pasteur

Investigators

  • Principal Investigator: Lucette Lacomblez, MD, Hôpital la Pitié Salpétrière, PARIS
  • Study Chair: Delphine Bohl, PhD, Institut Pasteur

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)

November 29, 2012

Primary Completion (Actual)

March 17, 2015

Study Completion (Actual)

March 17, 2015

Study Registration Dates

First Submitted

July 10, 2012

First Submitted That Met QC Criteria

July 10, 2012

First Posted (Estimate)

July 12, 2012

Study Record Updates

Last Update Posted (Actual)

May 1, 2018

Last Update Submitted That Met QC Criteria

April 27, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-33

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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