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Kadimastem – AstroRx

Kadimastem – AstroRx

Background

Kadimastem is a company located in Israel that is currently testing an “off-the-shelf”, clinical grade astrocyte cell product called AstroRx®. AstroRx® consists of astrocytes in suspension, derived from human embryonic stem cells. Astrocytes are neighbouring (glial) cells that provide support to motor neurons when healthy.

Data from an initial group of treated individuals (Cohort A) is presented in a press release from September 24th, 2019. Cohort A consisted of five participants with ALS treated intrathecally (in cerebrospinal fluid) with one dose of AstroRx® cells and evaluated for rate of disease progression over six months compared to the progression observed over the three months prior to treatment. The results stated that there was a “statistically significant decline in disease progression during the first 3-4 months after treatment was started” and that it serves as evidence for AstroRx® to provide “meaningful clinical benefit”. Kadimastem states that these results are “suggesting that a higher dose and/or repeated treatments may achieve prolonged efficacy”.

On December 23rd, 2019, Kadimastem announced that treatment with a higher dose of AstroRx® cells was provided to all five individuals in Cohort B with evaluation set for the next six months. Cohort C has been enrolled and involves repeated dose administration separated by 2-3 months. On August 3rd, 2020, results from Cohort B were provided in a press release that indicated the primary objective of safety was met, but also included claims about the efficacy. However, it should be noted that this was a study of only 5 people in each cohort and was primarily designed to test safety of the treatment. It is therefore very important that the data communicated in this release is not extrapolated by the public to indicate evidence about AstroRx® cells’ ability to slow ALS/MND progression.

A number of messages provided by Kadimastem could stimulate questions from people affected by ALS/MND. Kadimastem uses the slogan “cells to cure diseases” and the website explains that the goals of AstroRx® treatment include “replacing malfunctioning cells” and “restoring functionality”. The Chief Scientist states online that “This regenerative cell therapy promises to bring treatment and cure to millions of patients worldwide.” AstroRx® is also called a “breakthrough cell therapy”.

Recommendation

The SAC acknowledges the potential ability of healthy astrocytes to provide support to motor neuron health. Given the small size of Cohorts A and B, and the open label treatment of participants there is insufficient evidence to determine efficacy of AstroRx® in ALS/MND. There is presently no adequate evidence of efficacy with AstroRx treatment, neither has evidence been presented showing that AstroRx® could replace malfunctioning cells or restore functionality in humans. Caution should be taken when interpreting the results so far and should continue until a larger, properly controlled clinical trial has been completed.

 

 

International Alliance of ALS/MND Associations
September 2020

 


The original language of communication is English and any translation cannot be guaranteed for accuracy of messaging.

Primary Sidebar

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  • Carlos Gomez Matallanas, Diagnosed 2014 - FUNDELA, Spain

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  • Soledad Rodriguez, FUNDELA, Diagnosed 2013, Spain

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  • Joanne Pratt, Diagnosed 2011 - MND Australia

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  • Francisco Perez Palop, Diagnosed 2013 - FUNDELA, Spain

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  • Brigitte Wernli, Association ALS Switzerland, Diagnosed 2014, Switzerland

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  • Dorette Lüdi, Diagnosed 2014 - ALS Schweiz, Switzerland

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  • Nicholas (Nic) Bowman, MND Association of South Africa, Diagnosed 2016, Australia

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  • Len Johnrose, MND Association, Diagnosed 2017, England

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  • Inta Grubb, Diagnosed 2014 - MND Australia

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  • Antonio Ventriglia, ALS Liga Belgium, Diagnosed 2013, Belgium

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  • Mary Thomas, Diagnosed 2013 - MND Australia

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  • Ian Roberts

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  • Maurice LeClerc, ALS Canada

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  • Liong Ting Ngu, MND Malaysia, Diagnosed 2014, Malaysia

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  • Erwin Coppejans, Diagnosed 2007 - ALS Liga België, Belgium

    Erwin Coppejans, Diagnosed 2007 – ALS Liga België, Belgium

  • Chris McCauley, Diagnosed 2015 - ALS Canada

    Chris McCauley, Diagnosed 2015 – ALS Canada

  • Norm MacIsaac, ALS Society of Canada, ALS Society of Quebec, Diagnosed 2014, Canada

    Norm MacIsaac, ALS Society of Canada, ALS Society of Quebec, Diagnosed 2014, Canada

  • Danny Reviers, Diagnosed 1979 - ALS Liga België, Belgium

    Danny Reviers, Diagnosed 1979 – ALS Liga België, Belgium

  • Kirsten Harley, Diagnosed 2013 - Australia

    Kirsten Harley, Diagnosed 2013 – Australia

  • Susan Anderson, Diagnosed 2014 - Hope Loves Company, USA

    Susan Anderson, Diagnosed 2014 – Hope Loves Company, USA

  • Charlie “Hark” Dourney, Diagnosed 2007 - Hark ALS, USA

    Charlie “Hark” Dourney, Diagnosed 2007 – Hark ALS, USA

  • Roxana Canova, Diagnosed 2012 - Asociación ELA Argentina

    Roxana Canova, Diagnosed 2012 – Asociación ELA Argentina

  • Ailsa Malcolm-Hutton, Diagnosed 2013 - MND Association of England, Wales and N Ireland

    Ailsa Malcolm-Hutton, Diagnosed 2013 – MND Association of England, Wales and N Ireland

  • Steven Spencer, Diagnosed 2014 - MND New Zealand

    Steven Spencer, Diagnosed 2014 – MND New Zealand

  • Joyce Rusinak, Forbes Norris ALS Center, USA

    Joyce Rusinak, Forbes Norris ALS Center, USA

  • David Watson, MND Scotland, Diagnosed 2018, Scotland

    David Watson, MND Scotland, Diagnosed 2018, Scotland

  • Zabun Nassar, MND Association, Diagnosed 2016, England

    Zabun Nassar, MND Association, Diagnosed 2016, England

  • Rolf Mauch, Association ALS Switzerland, Diagnosed 2015, Switzerland

    Rolf Mauch, Association ALS Switzerland, Diagnosed 2015, Switzerland

  • Zelina-Brito-Diagnosed-2018-Brazil

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  • Josée Kolijn-de Man, Diagnosed 2015 - ALS Patients Connected, The Netherlands

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  • Mike Rannie, ALS Canada, Diagnosed 2017, Canada

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  • Marcel R. Wernard, Diagnosed 2016 - ALS Patients Connected, The Netherlands

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  • Conny van der Meijden, Diagnosed 2001 - ALS Netherlands

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  • Jon Newsome, Les Turner ALS Foundation, USA

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  • Lachlan Terry, MND Australia, Diagnosed 2015, Australia

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  • Monica Soriano, Diagnosed 2011 - Asociación ELA Argentina

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  • Joy Blakeley, Diagnosed 2017 - MND Australia

    Joy Blakeley, Diagnosed 2017 – MND Australia

  • Shay Rishoni, Diagnosed 2011 - Prize4Life, Israel

    Shay Rishoni, Diagnosed 2011 – Prize4Life, Israel

  • Alejandro Aquino, Diagnosed 2011 - Asociación ELA Argentina

    Alejandro Aquino, Diagnosed 2011 – Asociación ELA Argentina

  • Denis Blais, Diagnosed 2015 - ALS Canada

    Denis Blais, Diagnosed 2015 – ALS Canada

  • Glen Elison, ALS Hope Foundation, Diagnosed 2019, USA

    Glen Elison, ALS Hope Foundation, Diagnosed 2019, USA

  • Wilfried Leusing, Diagnosed 2010 - DGM, Germany

    Wilfried Leusing, Diagnosed 2010 – DGM, Germany

  • Duncan Bayly - MND Australia

    Duncan Bayly – MND Australia

  • Orlando Ruiz, Diagnosed 2001 - ACELA, Colombia

    Orlando Ruiz, Diagnosed 2001 – ACELA, Colombia

  • Sanjay Kumar Srivastava, Asha Ek Hope Foundation for ALS/MND, Diagnosed 2018, India

    Sanjay Kumar Srivastava, Asha Ek Hope Foundation for ALS/MND, Diagnosed 2018, India

  • Oliver Juenke, DGM, Germany

    Oliver Juenke, DGM, Germany

  • Karl Hughes, Diagnosed 2010 - IMNDA, Ireland

    Karl Hughes, Diagnosed 2010 – IMNDA, Ireland

  • Philip Brindle, MND Association, Diagnosed 2015, England

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  • Frank "Papa" Taylor

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Learn more about the March of Faces

Advocacy

  • Advocacy Toolkit
  • Rights of People with ALS/MND
  • Biogen – Tofersen
  • BrainStorm Cell Therapeutics – NurOwn
  • Collaborative Medicinal Development – CuATSM
  • Cytokinetics – Reldasemtiv
  • Right to Try
  • Unproven (Off-Label) Treatments
  • Amylyx – AMX0035
  • Kadimastem – AstroRx

Allied Professionals Forum Registration

The International Alliance of ALS/MND Associations will host a virtual Allied Professionals Forum spread over two days to accommodate time zones on 3 – 4 December 2020.

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