Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Institut Pasteur
Sponsor:
Information provided by (Responsible Party):
Institut Pasteur
ClinicalTrials.gov Identifier:
NCT01639391
First received: July 10, 2012
Last updated: December 5, 2012
Last verified: December 2012
  Purpose

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 Intervention
Amyotrophic Lateral Sclerosis
Procedure: skin biopsy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Creation of a Bank of Fibroblast From Patients With Amyotrophic Lateral Sclerosis: Pilot Study

Resource links provided by NLM:


Further study details as provided by Institut Pasteur:

Primary Outcome Measures:
  • Success of fibroblast culture, amplification, and freezing pellets [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Induced pluripotent Stem Cells generation success [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • neurones, motoneurones, glial cells obtention from fibroblasts or iPS [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: patients Procedure: skin biopsy
biopsy 5mm maximum on healthy skin under local anaesthesia.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Institut Pasteur
ClinicalTrials.gov Identifier: NCT01639391     History of Changes
Other Study ID Numbers: 2010-33
Study First Received: July 10, 2012
Last Updated: December 5, 2012
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

ClinicalTrials.gov processed this record on November 27, 2014