Creation of a Bank of Fibroblast From Patients With Amyot... | NCT01639391

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

NCT01639391

Sponsor

Institut Pasteur

Status

Completed

Last Update Posted

May 1, 2018Actual

Enrollment

19Actual

Phase

Not Applicable

Conditions

Amyotrophic Lateral Sclerosis

Interventions

skin biopsy

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 29, 2012Actual

Primary Completion Date

Mar 17, 2015Actual

Completion Date

Mar 17, 2015Actual

First Submitted Date

Jul 10, 2012

First Submission Date that Met QC Criteria

Jul 10, 2012

First Posted Date

Jul 12, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2018

Last Update Posted Date

May 1, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients	Experimental		Procedure: skin biopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
skin biopsy	Procedure	biopsy 5mm maximum on healthy skin under local anaesthesia.	patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Success of fibroblast culture, amplification, and freezing pellets		2 months

Secondary Outcomes

Measure	Description	Time Frame
Induced pluripotent Stem Cells generation success		2 years
neurones, motoneurones, glial cells obtention from fibroblasts or iPS		2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lucette Lacomblez, MD	hôpital La Pitié Salpêtrière, Paris	Principal Investigator
Delphine Bohl, PhD	Institut Pasteur	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre référent maladies rares SLA		Paris		75013	France

Condition Browse Module

MeSH Terms

ID	Term
D000690	Amyotrophic Lateral Sclerosis

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D016472	Motor Neuron Disease

Browse Leaves

Not provided

Browse Branches

Not provided