Amyotrophic Lateral SclerosisALSCELLNCT01639391
Creation of a Bank of Fibroblast From Patients With Amyotrophic Lateral Sclerosis: Pilot Study
A study testing skin biopsy in people with Amyotrophic Lateral Sclerosis, run by Institut Pasteur at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- skin biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 29 Nov 2012to 17 Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients over 18 years old
- ALS sporadic or familial or unknown
Who cannot join
- known cutaneous disease not allowing the biopsy
- platelets less than 10 000/m3
- suspected or known xylocain allergy
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- skin biopsy
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin biopsyProcedure or surgery
biopsy 5mm maximum on healthy skin under local anaesthesia.
| Study group | Role | What they receive |
|---|---|---|
| patients | Experimental | Not described Receives: Procedure: skin biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of fibroblast culture, amplification, and freezing pellets
Measured: 2 months
Secondary outcomes (2)
Induced pluripotent Stem Cells generation success
Measured: 2 years
neurones, motoneurones, glial cells obtention from fibroblasts or iPS
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2012 (estimated)
- Study start29 Nov 2012
- Primary completion17 Mar 2015
- Study completion17 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by Institut PasteurThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lucette Lacomblez, MD, Principal investigator, hôpital La Pitié Salpêtrière, ParisDelphine Bohl, PhD, Study chair, Institut Pasteur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01639391
- Sponsor's protocol ID
- 2010-33
- Acronym
- ALSCELL
- Status last verified
- Apr 2018
- First submitted
- 10 Jul 2012
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation of a Bank of Fibroblast From Patients With Amyotrophic Lateral Sclerosis: Pilot Study
- ClinicalTrials.gov ID
- NCT01639391
- Acronym / sponsor ID
- ALSCELL / 2010-33
- Conditions
- Amyotrophic Lateral Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2012 (actual)
- Primary completion
- 17 Mar 2015 (actual)
- Study completion
- 17 Mar 2015 (actual)
- First posted
- 12 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | Experimental | Procedure: skin biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients over 18 years old
- ALS sporadic or familial or unknown
Key exclusion criteria (3 listed)
- known cutaneous disease not allowing the biopsy
- platelets less than 10 000/m3
- suspected or known xylocain allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| skin biopsybiopsy 5mm maximum on healthy skin under local anaesthesia. | Procedure or surgery | patients |
Primary outcome
Success of fibroblast culture, amplification, and freezing pellets
Time frame: 2 months
2 secondary outcomes
Induced pluripotent Stem Cells generation success
Time frame: 2 years
neurones, motoneurones, glial cells obtention from fibroblasts or iPS
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucette Lacomblez, MD principal investigator
hôpital La Pitié Salpêtrière, Paris
Delphine Bohl, PhD study chair
Institut Pasteur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing skin biopsy in people with Amyotrophic Lateral Sclerosis, run by Institut Pasteur at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of fibroblast culture, amplification, and freezing pellets (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2018.