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NCT06450691Recruiting

Modeling Amyotrophic Lateral Sclerosis With Fibroblasts

Modeling of Amyotrophic Lateral Sclerosis Using Patient Fibroblasts to Study Different Form of the Disease.

Source: ClinicalTrials.gov · Last updated 13 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
110 (estimated)
First submitted
5 Jun 2024
Start date
28 Aug 2025
Primary completion date
Sept 2034
Lead sponsor
Assistance Publique - Hôpitaux de Paris
NCT number
NCT06450691

What you commit to

  • Study type: Interventional
  • Planned participants: 110
  • From 28 Aug 2025 to the primary completion date, Sept 2034
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participation in a clinical trial (involving a drug) or other interventional research if this interferes with FIBRALS research.

Other illness

  • 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
  • with a proven allergy to lidocaine or prilocaine,
  • Patient's condition which, in the opinion of the investigator, is incompatible with skin sampling or participation in the study.

Lab values

  • have a platelet count of less than 75,000/mm3 in a laboratory test less than 3 months old,

Other

  • Pregnant or breast-feeding women, or subjects under guardianship, curatorship or safeguard of justice.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CIC Neurosciences
Coordinator of this site? Confirm its status
ParisFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.