Back to resultsCreation of a Bank of Fibroblast From Patients With Amyotrophic Lateral Sclerosis: Pilot Study (ALSCELL)
Primary Purpose
Amyotrophic Lateral Sclerosis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
skin biopsy
Sponsored by
About this trial
This is an interventional basic science trial for Amyotrophic Lateral Sclerosis
Eligibility Criteria
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
Sites / Locations
- Centre référent maladies rares SLA
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patients
Arm Description
Outcomes
Primary Outcome Measures
Success of fibroblast culture, amplification, and freezing pellets
Secondary Outcome Measures
Induced pluripotent Stem Cells generation success
neurones, motoneurones, glial cells obtention from fibroblasts or iPS
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01639391
Brief Title
Creation of a Bank of Fibroblast From Patients With Amyotrophic Lateral Sclerosis: Pilot Study
Acronym
ALSCELL
Official Title
Creation of a Bank of Fibroblast From Patients With Amyotrophic Lateral Sclerosis: Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
November 29, 2012 (Actual)
Primary Completion Date
March 17, 2015 (Actual)
Study Completion Date
March 17, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Pasteur
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
skin biopsy
Intervention Description
biopsy 5mm maximum on healthy skin under local anaesthesia.
Primary Outcome Measure Information:
Title
Success of fibroblast culture, amplification, and freezing pellets
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Induced pluripotent Stem Cells generation success
Time Frame
2 years
Title
neurones, motoneurones, glial cells obtention from fibroblasts or iPS
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucette Lacomblez, MD
Organizational Affiliation
hôpital La Pitié Salpêtrière, Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Delphine Bohl, PhD
Organizational Affiliation
Institut Pasteur
Official's Role
Study Chair
Facility Information:
Facility Name
Centre référent maladies rares SLA
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
Learn more about this trial
Creation of a Bank of Fibroblast From Patients With Amyotrophic Lateral Sclerosis: Pilot Study
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