Using Skin Cells to Study Amyotrophic Lateral Sclerosis
Modeling Amyotrophic Lateral Sclerosis With Fibroblasts
Recruiting
N/AInterventional Study
Amyotrophic Lateral Sclerosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Other
Participants needed
110 (estimated)
Sponsor
Assistance Publique - Hôpitaux de Paris · Other
Who this trial is looking for
This trial is looking for adults with ALS, people who carry genes for ALS but have no symptoms, and healthy controls. Participants will provide skin and blood samples at specific visits to help researchers understand ALS better.
Are You a Good Fit for This Trial?
You may be able to join if
I am an adult.
I agree to take part in the study.
I am covered by a social security scheme.
I have been diagnosed with ALS.
I carry a gene mutation for ALS but have no symptoms.
I am a healthy individual matched by age and sex.
You may not be able to join if
I have a known skin disease that affects skin biopsy.
I have a low platelet count.
I am allergic to lidocaine or prilocaine.
I am pregnant or breastfeeding.
I am under guardianship or similar legal protection.
My condition makes it unsafe for me to participate.
I am participating in another clinical trial that could interfere.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Amyotrophic Lateral Sclerosis (ALS) is the most common motor neuron disease in adults. This longitudinal study involves three cohorts of participants: patients with sporadic or hereditary ALS, asymptomatic individuals carrying pathogenic mutations responsible for ALS, and control subjects. In this study, a skin biopsy and blood sampling will be performed at the initial visit (M0), then at M12 (+/-…
Amyotrophic Lateral Sclerosis (ALS) is the most common motor neuron disease in adults. This longitudinal study involves three cohorts of participants: patients with sporadic or hereditary ALS, asymptomatic individuals carrying pathogenic mutations responsible for ALS, and control subjects. In this study, a skin biopsy and blood sampling will be performed at the initial visit (M0), then at M12 (+/- 2 months) for patients, and at M36 (+/- 12 months) for asymptomatic carriers of pathogenic mutations. The aim of this research is to model ALS pathology using fibroblasts derived from the patients' skin biopsies.
Trial Locations
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Eligibility Criteria
Inclusion criteria common to all 3 populations:
* adults, both sexes
* with written consent to participate in the study
* affiliated to a social security scheme
ALS patients :
* patients with ALS according to the revised El Escorial criteria :
* with a hereditary form of ALS, defined by the prese…
Inclusion criteria common to all 3 populations:
* adults, both sexes
* with written consent to participate in the study
* affiliated to a social security scheme
ALS patients :
* patients with ALS according to the revised El Escorial criteria :
* with a hereditary form of ALS, defined by the presence of a family history of ALS or by the demonstration of a pathogenic mutation in the patient or
* with a juvenile form of the disease, defined by onset of symptoms at less than 30 years of age or
* with a sporadic form of ALS
Asymptomatic mutation carriers :
\- Asymptomatic individuals who carry a mutation causing ALS but have not developed symptoms.
Healthy subjects:
* control individuals, taking into account male/female and close age matching
Exclusion Criteria:
* with a known skin disease (acne, atopic dermatitis, psoriasis, melanoma, skin carcinoma, rosacea, scabies; as referenced on http://dermato-info.fr/), which in the investigator's opinion constitutes a contraindication to skin biopsy
* have a platelet count of less than 75,000/mm3 in a laboratory test less than 3 months old,
* with a proven allergy to lidocaine or prilocaine,
* Pregnant or breast-feeding women, or subjects under guardianship, curatorship or safeguard of justice.
* Patient's condition which, in the opinion of the investigator, is incompatible with skin sampling or participation in the study.
* Participation in a clinical trial (involving a drug) or other interventional research if this interferes with FIBRALS research.
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