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
6 month follow up results for Cohort B have been reported
Clinical grade pancreatic islet cells which produce and secrete insulin and glucagon in response to blood glucose levels
A unique micro-encapsulation technology, integrated within IsletRx, protects the islet cells from the host immune system, this allowing prolonged therapeutic effect overcoming a major challenge faced by the Cell Therapy industry
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.
Clinical Trial on ALS Patients using our Innovative Cell Therapy
The Company conducted a phase 1/2a clinical trial on ALS patients
The trial was conducted at Hadassah Ein Kerem Hospital in Jerusalem a world leading center in the field of ALS
The trial included 10 ALS patients
The Company has completed treatment (cell transplantation of AstroRx®) in 10 patients of Cohort A and B
The company has received approval from the MOH of Israel to commence our phase I/IIa clinical trial in ALS patients
Results of Cohort A and interim results for the Cohort B have been published on our press release page.
6 Mo. results for the Cohort B were published in December or 2020
"The results after 6 months of follow up are encouraging, as they suggest a clinically meaningful signal of effect for a period of 3 months by a single administration of AstroRx® and confirm the safety of AstroRx®. These results support a further, randomized-controlled, clinical trial with repeated doses of AstroRx® in patients with ALS, in order to prolong the clinical effect observed by a single dose," stated Dr. Marc Gotkine, Head of the ALS Clinic at the Department of Neurology at Hadassah Medical Center, Jerusalem, and the Principal Investigator of the trial.
The Company reports that study objectives have been achieved, as study results show safe delivery of IsletRx and demonstrate efficacy manifested by prolonged normalized blood sugar levels in treated immunocompetent diabetic mice throughout the duration of the preclinical study (3 months). Furthermore, no disease or treatment related complications were observed, and all treated animals remained healthy throughout study duration. In comparison, a control group of non-treated diabetic mice presented severe hyperglycemia, leading to the death of the non-treated mice within 40 days.
IsletRx for Diabetes
We Have Reached Successful Pre-clinical results of our cell Therapy Treatment for Insulin-Dependent 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 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 IsletRx contains pancreatic islet cells which produce and secrete insulin and glucagon in response to blood glucose levels. IsletRx is produced utilizing proprietary method of the Company, which includes a unique stage for enrichment for functionally active cells using newly specific cell surface biomarkers. In addition, a unique micro-encapsulation technology, integrated within IsletRx, protects the islet cells from the host immune system, without the need for potentially toxic immunosuppressive drug treatment and allows for prolonged therapeutic effect, demonstrated in pre-clinical studies. IsletRx is intended for the treatment of Insulin Dependent Diabetes, aiming to free patients from continuous monitoring of blood sugar levels and repeated insulin injections.
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.