A Study to Evaluate Transplantation of Astrocytes Derived From Human Embryonic Stem Cells, in Patients With Amyotrophic Lateral Sclerosis (ALS)
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ClinicalTrials.gov Identifier: NCT03482050 |
Recruitment Status :
Completed
First Posted : March 29, 2018
Last Update Posted : January 15, 2021
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Tracking Information | |||||
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First Submitted Date ICMJE | March 14, 2018 | ||||
First Posted Date ICMJE | March 29, 2018 | ||||
Last Update Posted Date | January 15, 2021 | ||||
Actual Study Start Date ICMJE | April 12, 2018 | ||||
Actual Primary Completion Date | June 22, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Number of participants with treatment emergent adverse events as assessed by CTCAE Version 4.03 [ Time Frame: 11 Months ] Safety and tolerability assessment will be based on treatment emerged adverse events
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Study to Evaluate Transplantation of Astrocytes Derived From Human Embryonic Stem Cells, in Patients With Amyotrophic Lateral Sclerosis (ALS) | ||||
Official Title ICMJE | A Phase I/IIa, Open Label, Dose-escalating Clinical Study to Evaluate the Safety, Tolerability and Theraputic Effects of Transplantation of Astrocytes Derived From Human Embryonic Stem Cells (hESC), in Patients With Amyotrophic Lateral Sclerosis (ALS) | ||||
Brief Summary | This is a study of transplantation of Astrocytes derived from human embryonic stem cells, in patients with Amyotrophic Lateral Sclerosis (ALS). There will be no change in the routine ALS treatment of the patients enrolled into the study. Treatment will be administered in addition to the appropriate standard of care treatment. The study hypothesis is that transplantation of Astrocyte(AstroRx) cells can compensate for the malfunctioning of patients' own astrocytes by restoring physiological capabilities like the reuptake of excessive glutamate, reducing oxidative stress, reducing other toxic compounds, as well as by secreting different neuroprotective factors |
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Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: N/A Intervention Model: Sequential Assignment Intervention Model Description: Dose-escalating, four subject-groups clinical study; a single treatment administration of AstroRx, administered in an escalating low, medium and high dose or two consecutive administrations of the medium dose separated by an interval. AstroRx will be administered by intrathecal (spinal) injection to subjects with ALS at the early disease stage. Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | ALS (Amyotrophic Lateral Sclerosis) | ||||
Intervention ICMJE | Biological: AstroRx
Astrocytes derived from human embryonic stem cells
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Study Arms ICMJE | Experimental: AstroRx
Intervention: Biological: AstroRx
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
16 | ||||
Original Estimated Enrollment ICMJE |
21 | ||||
Actual Study Completion Date ICMJE | June 22, 2020 | ||||
Actual Primary Completion Date | June 22, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Main Inclusion Criteria:
Main Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Israel | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03482050 | ||||
Other Study ID Numbers ICMJE | ASTRO-001-IL | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Kadimastem | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Kadimastem | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Kadimastem | ||||
Verification Date | January 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |