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NCT01639391 Clinical Trial

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

Amyotrophic Lateral Sclerosis Clinical Trial

— ALSCELL  

Official title:
Creation of a Bank of Fibroblast From Patients With Amyotrophic Lateral Sclerosis: Pilot Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01639391
Other study ID # 2010-33
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 29, 2012
Est. completion date March 17, 2015

Study information
Verified date April 2018
Source Institut Pasteur
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 19
Est. completion date March 17, 2015
Est. primary completion date March 17, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• skin biopsy
biopsy 5mm maximum on healthy skin under local anaesthesia.

Locations
Country Name City State
France Centre référent maladies rares SLA Paris

Sponsors (1)
Lead Sponsor Collaborator
Institut Pasteur

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Success of fibroblast culture, amplification, and freezing pellets 2 months
Secondary Induced pluripotent Stem Cells generation success 2 years
Secondary neurones, motoneurones, glial cells obtention from fibroblasts or iPS 2 years
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