Clinical trial • Phase IV • Neurology | Musculoskeletal
Autologous bone marrow-derived stem cells for Amyotrophic lateral sclerosis
Phase IV trial of Autologous bone marrow-derived stem cells for Amyotrophic lateral sclerosis. 100 participants.
Overview
- Trial Therapeutic Area
- Neurology | Musculoskeletal
- Trial Disease
- Amyotrophic lateral sclerosis
- Trial Stage
- Phase IV
- Drug Modality
- Cell therapy
Key dates
- Initial CTIS Submission Date
- 08-10-2024
- First CTIS Authorization Date
- 05-11-2024
Trial design
Phase IV trial across 2 sites in Spain.
- Target Sample Size
- 100
- Trial Duration For Participant
- 1827
Eligibility
Recruits 100 Vulnerable population not selected; no details on consent or assent provided..
- Vulnerable Population
- Vulnerable population not selected; no details on consent or assent provided.
Recruitment
- Planned Sample Size
- 100
- Recruitment Window Months
- 60
- Consent Approach
- No information provided on informed consent or assent; not specified.
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 100
Spain
- Earliest CTIS Part Ii Submission Date
- 17-10-2024
- Latest Decision Or Authorization Date
- 05-11-2024
- Processing Time Days
- 19
- Number Of Sites
- 2
- Number Of Participants
- 100
Sites
- Site Name
- Hospital General Universitario Dr. Balmis
- Department Name
- Neurology
- Contact Person Name
- Carmen Díaz Marín
- Contact Person Email
- carmina.diaz.marin@gmail.com
- Site Name
- University Clinical Hospital Virgen De La Arrixaca
- Department Name
- Hematology
- Contact Person Name
- Miguel Blanquer Blanquer
- Contact Person Email
- miguelblanquer@gmail.com
Sponsor
Primary sponsor
- Full Name
- Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- Autologous bone marrow-derived stem cells (intramuscular infusion)
- Active Substance
- Autologous bone marrow-derived stem cells
- Modality
- Cell therapy
- Routes Of Administration
- Intramuscular
- Route
- Intramuscular
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