NCT07099066

Brief Summary

The aim of this research is to establish different cell banks from patients with amyotrophic lateral sclerosis (ALS).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
1mo left

Started Sep 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Sep 2025Jun 2026

First Submitted

Initial submission to the registry

July 18, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 1, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

7 months

First QC Date

July 18, 2025

Last Update Submit

July 25, 2025

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Keywords

Amyotrophic Lateral Sclerosis (ALS)

Outcome Measures

Primary Outcomes (1)

  • Cell banking

    Number of cell batches cryopreserved that meet predefined quality criteria (cell viability ≥ 80%, absence of mycoplasma). Data will be summarized as percentage of compliant batches over total batches produced.

    8 months

Study Arms (1)

ALS patients

Other: sampling blood

Interventions

sampling bloodOTHER

3 types of sampling : urine, skin and blood.

ALS patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ALS patients who are part of a cohort from the ALS Center of Toulouse University Hospital and are treated at that hospital.

You may qualify if:

  • Subjects over 18 years old;
  • Subjects who have given their consent and signed an informed, free and express consent form;
  • Subjects with diagnosed ALS;
  • Subjects affiliated to or benefiting from a social security scheme.

You may not qualify if:

  • Subjects with contraindications to the collection of biological samples (blood, skin, urine).
  • Subjects with hereditary or acquired haemostasis disorders;
  • Subjects who have undergone physical treatment (radiotherapy, etc.) on the area to be biopsied in the last 6 months;
  • Lidocaine-intolerant subjects;
  • Subjects who have reached the age of majority and are subject to a protective measure or are unable to express their consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples.

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Cordocentesis

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Blood Specimen CollectionSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisParacentesisPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2025

First Posted

August 1, 2025

Study Start

September 1, 2025

Primary Completion

April 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

August 1, 2025

Record last verified: 2025-07