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CompletedNCT01639391ALSCELLUpdated May 1, 2018

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

An interventional study of skin biopsy in Amyotrophic Lateral Sclerosis, sponsored by Institut Pasteur. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-01.

Sponsored by Institut Pasteur · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

03

In context

Motor Neuron Disease

717 studies on the registry are indexed under Motor Neuron Disease; 137 are open to participants now.

This study's enrollment of 19 is below the median of 35 across 461 interventional studies indexed under Motor Neuron Disease.

Browse Motor Neuron Disease studies →

Lead sponsor

Institut Pasteur is the lead sponsor of 96 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • known cutaneous disease not allowing the biopsy
  • platelets less than 10 000/m3
  • suspected or known xylocain allergy
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    patients

    Procedure: skin biopsy

Interventions

  • Procedureskin biopsy

    biopsy 5mm maximum on healthy skin under local anaesthesia.

06

What researchers measure

Primary outcomes

  1. Success of fibroblast culture, amplification, and freezing pellets

    Time frame: 2 months

Secondary outcomes

  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

07

Study locations

1 site
  • Centre référent maladies rares SLA
    Paris, 75013, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01639391
Lead sponsor
Institut Pasteur
Responsible party
Sponsor
First posted
Jul 12, 2012
Start date
Nov 29, 2012
Primary completion
Mar 17, 2015
Completion
Mar 17, 2015
Last update
May 1, 2018

Study contacts

Lucette Lacomblez, MD
principal investigator · hôpital La Pitié Salpêtrière, Paris
Delphine Bohl, PhD
study chair · Institut Pasteur

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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