NCT01639391

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 12, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

November 29, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2015

Completed
Last Updated

May 1, 2018

Status Verified

April 1, 2018

Enrollment Period

2.3 years

First QC Date

July 10, 2012

Last Update Submit

April 27, 2018

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Success of fibroblast culture, amplification, and freezing pellets

    2 months

Secondary Outcomes (2)

  • Induced pluripotent Stem Cells generation success

    2 years

  • neurones, motoneurones, glial cells obtention from fibroblasts or iPS

    2 years

Study Arms (1)

patients

EXPERIMENTAL
Procedure: skin biopsy

Interventions

skin biopsyPROCEDURE

biopsy 5mm maximum on healthy skin under local anaesthesia.

patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre référent maladies rares SLA

Paris, 75013, France

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Lucette Lacomblez, MD

    hôpital La Pitié Salpêtrière, Paris

    PRINCIPAL INVESTIGATOR

  • Delphine Bohl, PhD

    Institut Pasteur

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2012

First Posted

July 12, 2012

Study Start

November 29, 2012

Primary Completion

March 17, 2015

Study Completion

March 17, 2015

Last Updated

May 1, 2018

Record last verified: 2018-04

Locations

FR(1)