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

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ClinicalTrials.gov Identifier: NCT01639391
Recruitment Status : Unknown
Verified December 2012 by Institut Pasteur.
Recruitment status was:  Recruiting
First Posted : July 12, 2012
Last Update Posted : December 6, 2012
Sponsor:
Information provided by (Responsible Party):
Institut Pasteur

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).


Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Procedure: skin biopsy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Creation of a Bank of Fibroblast From Patients With Amyotrophic Lateral Sclerosis: Pilot Study
Study Start Date : November 2012
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : August 2014


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



Primary Outcome Measures :
  1. Success of fibroblast culture, amplification, and freezing pellets [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Induced pluripotent Stem Cells generation success [ Time Frame: 2 years ]
  2. neurones, motoneurones, glial cells obtention from fibroblasts or iPS [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01639391


Locations
France
Centre référent maladies rares SLA Recruiting
Paris, France, 75013
Contact: Lucette Lacomblez, MD       vanessa.pibiri@psl.aphp.fr   
Contact: Vanessa Pibiri       vanessa.pibiri@psl.aphp.fr   
Principal Investigator: Lucette Lacomblez, MD         
Sponsors and Collaborators
Institut Pasteur
Investigators
Principal Investigator: Lucette Lacomblez, MD hôpital La Pitié Salpêtrière, Paris
Study Chair: Delphine Bohl, PhD Institut Pasteur

Responsible Party: Institut Pasteur
ClinicalTrials.gov Identifier: NCT01639391     History of Changes
Other Study ID Numbers: 2010-33
First Posted: July 12, 2012    Key Record Dates
Last Update Posted: December 6, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Sclerosis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases