Company Pipeline

AstroRx® 

  • Clinical grade human astrocytes (the nervous system supporting cells) for the treatment of ALS and other neurodegenerative diseases

  • Received approval by the Israeli Ministry of Health to commence our phase I/IIa clinical trial in ALS patients. 

  • Patient enrollment in Q2/2018 

Incapsulin

  • Clinical-grade pancreatic islet-like cells encapsulated in a medical device

  • The cells produce insulin and other hormones that normalize blood glucose, for use as encapsulated implants in the treatment of Diabetes

AstroRx® for ALS

AstroRx® - Functional Healthy Astrocytes to Protect ALS-Diseased Motor Neurons.

ALS is a rapidly progressive and fatal neurological disease, causing death on average within 3-5 years from time of diagnosis. The disease attacks motor neurons responsible for controlling muscles and leads to paralysis and impaired breathing and swallowing. Multiple studies have demonstrated that astrocytes play a crucial role in ALS disease progression. In ALS patients, the astrocytes malfunction and attack the neurons.

 

Kadimastem's innovative approach is to use fully differentiated astrocytes as a regenerative medicine therapy for ALS – AstroRx® to slow the progression of the disease and improve the patient's life quality and life expectancy. AstroRx® is administered directly into the patient’s spinal cord fluid by a standard intrathecal injection under local anesthesia. Pre-clinical studies in ALS animal models showed that AstroRx® is a safe treatment that provides systemic support to damaged motor neurons, increasing the life expectancy and motor functions.

 

Innovative Clinical Trial in ALS Patients

The company is conducting a phase 1/2a clinical trial in ALS patients

(https/iclinicaltrials.goylct2/showiNCT03482050) 

The trial is being conducted at Hadassah Ein Kerem Hospital in Jerusalerna world leading center in the field of ALS 

 

Study Design:

  • The trial includes 21 ALS patients (4 treatment cohorts)

  • The company has completed treatment (cell transplantation of AstroRx®) in 5 patients of Cohort A.

  • The company has received approval from the MOH of Israel to continue cell transplantation of five additional ALS patients recruited for Cohort B.

  • According to the clinical protocol in Cohort B, ALS patients will be treated with 2.5 times the number of cells as Cohort A.

  • Results for the Cohort B are expected by the end of 2019.

Patient recruitment Information for Inquiries Contact:

Chen | +972-2-| HCRC_ALS@hadassah.org.il

 

Diabetes

Encapsulated Islet-of-Langerhans-Like Clusters to Cure Diabetes

Diabetes mellitus is a chronic disorder characterized by high blood glucose levels and glucose intolerance, due to insulin deficiency, impaired effectiveness of insulin action, or both. Diabetes is classified on the basis of cause and clinical presentation of the disorder into two major types:  type 1 and type 2 diabetes. In Type 1 diabetes pancreatic islets are destroyed, causing deficiency in insulin production and secretion. It currently requires daily glucose monitoring and injection of exogenous insulin. Type 2 diabetes results from insulin resistance, in which the body fails to use insulin properly.

Kadimastem's product is comprised of islet-of-Langerhans-like clusters which produce and secrete insulin and glucagon in response to external sugar levels. These cells can restore the patient’s ability to produce and release insulin and glucagon in response to changes in blood glucose, reduce the need for continuous monitoring of blood sugar levels and replacing insulin injections. When encapsulated in a device, the cells are protected from immune rejection yet are able to perform both glucose sensing and insulin secretion. It is Kadimastem's priority to select a partner with technological capabilities suitable for application in the company's cell-based product for diabetes.

The number of patients with diabetes was estimated to be over 366 million worldwide in 2011 and is projected to be more than 552 million in 2030.  The American Diabetes Association (ADA) estimated the total annual costs of diabetes to be US$223.5 billion (in the US alone). The global cost is estimated to be US$465 billion annually and will grow to about US$510 billion by 2030.

© 2019 by Kadimastem

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