Trials / Completed
CompletedNCT03482050
A Study to Evaluate Transplantation of Astrocytes Derived From Human Embryonic Stem Cells, in Patients With Amyotrophic Lateral Sclerosis (ALS)
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)
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Kadimastem · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | AstroRx | Astrocytes derived from human embryonic stem cells |
Timeline
- Start date
- 2018-04-12
- Primary completion
- 2020-06-22
- Completion
- 2020-06-22
- First posted
- 2018-03-29
- Last updated
- 2021-01-15
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT03482050. Inclusion in this directory is not an endorsement.