A Study to Evaluate Transplantation of Astrocytes Derived From Human Embryonic Stem Cells, in Patients With Amyotrophic Lateral Sclerosis (ALS)

Study Purpose:

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

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Interventional Trial

Study Category:

Stem Cell

Study Status:

Enrolling

Phase:

Phase I ,Phase II

Study Chair(s)/Principal Investigator(s):

Marc Gotkine, MD, Hadassah Ein Kerem Medical Center

Clinicaltrials.gov ID (11 digit #):

NCT03482050

Neals Affiliated?

No

Coordinating Center Contact Information

Hadassah Ein Kerem Medical Center
Yael Feinsod / .(JavaScript must be enabled to view this email address) / +972-2-6779372
.(JavaScript must be enabled to view this email address) Jerusalem, Israel

Full Study Summary:

Study Sponsor:

Kadimastem

Participant Duration:

Estimated Enrollment:

21

Estimated Study Start Date:

03/31/2018

Estimated Study Completion Date:

07/31/2020

Posting Last Modified Date:

05/29/2018

Date Study Added to alsconsortium.org:

04/04/2018
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    70

    Min Vital Capacity (% predicted normal):

    70

    Time since Symptom Onset:

    N/A

    Time since Diagnosis:

    <24 months

    Can participants use Riluzole?

    Yes


    Main Inclusion Criteria:

    El Escorial criteria for probable or definite ALS
    Males and and non pregnant females between 18 and 70 years of age
    Patients with an ALS-FRS-R score of at least 30 with an ALS diagnosis of two years or less
    No history of active psychiatric disorder.
    Patient has a good understanding of the study and nature of the procedure
    Patient provides written informed consent prior to any study procedure
    Patients should either be on a stable dose of Riluzole and/or Radicava® (if applicable) for 3 months, or not be treated with Riluzole or Radicava®
    Patient is medically able to tolerate immunosuppression regimen
    Presence of a willing and able caregiver who understands the need to attend all follow-up visits, even if mobility declines

    Main Exclusion Criteria:

    Patient has a past infection or a positive test for HBV,HCV or HIV
    Patient is in need of respiratory support
    Patient has a lower than 10/12 in ALS-FRS-R respiratory parameters or below 70% of predicted slow vital capacity (SVC)
    Patient has renal failure
    Patient has impaired hepatic function
    Patient has a Body Mass Index (BMI) of <18.5 or > 30
    Patient suffers from significant cardiac disease, diabetes, autoimmune diseases, chronic severe infection, malignant disease or any other disease or condition that may risk the patient or interfere with the ability to interpret the study results
    Patient has systemic inflammation or active infections
    Patient has been treated previously with any stem cell therapy
    Current use of immunosuppressant medication or use of such medication within 6 weeks of Screening visit (Visit 0)
    Patient has participated in another clinical treatment trial or received other experimental medications outside of a clinical trial within 1 month prior to start of this study
    Any known immunodeficiency syndrome
    Any concomitant disease or condition limiting patient safety to participate

  • Site Contact Information

    Hadassah Ein Kerem Medical Center
    Yael Feinsod / .(JavaScript must be enabled to view this email address) / +972-2-6779372
    Jerusalem,
    Israel