Amyotrophic Lateral Sclerosis (ALS)HCD-SLANCT07099066
Generation of Cell Banks and Biomarker Isolation From Patients With Amyotrophic Lateral Sclerosis (ALS) (HCD-SLA)
An observational study of Amyotrophic Lateral Sclerosis (ALS), run by Human Cell Design.
Trial summary
The aim of this research is to establish different cell banks from patients with amyotrophic lateral sclerosis (ALS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis (ALS)
- What is being tested?
- sampling blood
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: ALS patients who are part of a cohort from the ALS Center of Toulouse University Hospital and are treated at that hospital.
Who may be able to join
- 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.
Who cannot join
- Subjects with contraindications to the collection of biological samples (blood, skin, urine).
- Subjects undergoing treatment likely to affect hemostasis (anticoagulants, platelet anti-aggregants, etc.) in the month prior to inclusion and during the study;
- 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.
About this study
Official title: Generation of Skin Fibroblast Banks, Urine-derived Cells and Biomarker Isolation From Patients With Amyotrophic Lateral Sclerosis (Als)
The aim of this research is to establish different cell banks from patients with amyotrophic lateral sclerosis (ALS).
Read the detailed description
The objective of this research is to:
- Create banks of skin fibroblasts from skin biopsy samples
- Create banks of urine-derived cells (UDCs) from urine samples
- Build a collection of blood samples to enable isolation of biomarkers.
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Being tested
- sampling blood
- Keywords
- Amyotrophic Lateral Sclerosis (ALS)
- 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.
sampling bloodOther
3 types of sampling : urine, skin and blood.
| Study group | Role | What they receive |
|---|---|---|
| ALS patients | Not described Receives: Other: sampling blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral Sclerosis (ALS)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Human Cell Design
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099066
- Sponsor's protocol ID
- 2025-A00776-43
- Acronym
- HCD-SLA
- Status last verified
- Jul 2025
- First submitted
- 18 Jul 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generation of Skin Fibroblast Banks, Urine-derived Cells and Biomarker Isolation From Patients With Amyotrophic Lateral Sclerosis (Als)
- ClinicalTrials.gov ID
- NCT07099066
- Acronym / sponsor ID
- HCD-SLA / 2025-A00776-43
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Keywords
- Amyotrophic Lateral Sclerosis (ALS)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Human Cell DesignIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 1 Aug 2025 (actual)
- 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.
The aim of this research is to establish different cell banks from patients with amyotrophic lateral sclerosis (ALS).
Detailed description
The objective of this research is to:
- Create banks of skin fibroblasts from skin biopsy samples
- Create banks of urine-derived cells (UDCs) from urine samples
- Build a collection of blood samples to enable isolation of biomarkers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALS patients | – | Other: sampling blood |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ALS patients who are part of a cohort from the ALS Center of Toulouse University Hospital and are treated at that hospital.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- Subjects with contraindications to the collection of biological samples (blood, skin, urine).
- Subjects undergoing treatment likely to affect hemostasis (anticoagulants, platelet anti-aggregants, etc.) in the month prior to inclusion and during the study;
- 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;
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 |
|---|---|---|
| sampling blood3 types of sampling : urine, skin and blood. | Other | ALS patients |
Primary outcome
Cell banking
Time frame: 8 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
Related trials for Amyotrophic Lateral Sclerosis (ALS)
RecruitingPhase 1/2
Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS
Amyotrophic Lateral Sclerosis
Not yet recruiting
A Study on the Addition of Alsum30 for the Treatment of Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis (ALS), Bacillus Coagulans
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Not yet recruitingPhase 1
Safety, Tolerability, and Pharmacodynamic Exploration of Orelabrutinib in Patients With Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis (ALS)
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis (ALS), run by Human Cell Design.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Cell banking (time frame: 8 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 Aug 2025.