Matters of the Heart

ISSUE #64 – Alexandre Civière, Project Manager at CellProthera, talks about research and breakthroughs in the regeneration of heart muscle after a severe heart attack and the prevention of congestion heart failure.

 

Can you tell us about CellProthera and its therapeutic approach?

cellprothera singapour french chamber smart healthCellProthera was founded in 2008 in Mulhouse, France, to research, develop and commercialise innovative therapeutic solutions for the regeneration of organs damaged by disease or trauma but also to develop the means to industrialise cell manufacturing in a cost-effective manner.

CellProthera therapy focuses on the development of an approach allowing the regeneration of myocardial tissue to treat heart attack and prevent secondary congestive heart failure.

CellProthera’s innovative solution was successfully tested in a proof-of-concept clinical study started in 2002 using stem cells directly reinjected into the cardiac lesion of patients after heart attack. The clinical outcomes indicated an excellent safety profile associated with a long-term outstanding recovery of their cardiac function, which allowed the study patients to return to a normal life.

The unique therapeutic approach requires a simple blood sampling best performed a few weeks after a severe heart attack. The sampling occurs after a treatment period, using a cell-stimulating factor in order to mobilise the patient’s own stem cells from the bone marrow to the blood flow. The patient’s blood sample is then forwarded to a local certified Cell Therapy centre and processed in our proprietary automated device StemXpand® in order to expand the number of CD34+ stem cells. The final graft product obtained is called ProtheraCytes®.

When injected into scar tissue within the heart wall, CD34+ stem cells have experimentally shown in nude mice the capability to engraft in the damaged tissue and to differentiate into mature cardiac and vessel cells. Preclinical tests carried out on grafts collected from peripheral blood of healthy donors have shown excellent results.

By using adult stem cells obtained from a patient’s own body, this therapeutic approach avoids all challenges currently faced by other types of cell-based clinical therapies including tissue rejection and immunosuppressive treatments.

CellProthera therapy focuses on the development of an approach allowing the regeneration of myocardial tissue to treat heart attack and prevent secondary congestive heart failure.

What is the long-term vision of this approach?

In the long run, CellProthera’s therapeutic goal is to extend this cell therapy to regenerate other organs based on the same technology platform: as blood vessel diseases or cartilage.

CellProthera’s devices and prototypes, have successfully passed biological validation and have been approved by regulatory bodies. A commercial version is under development, which would allow the production of five grafts simultaneously instead of one at present.

Furthermore, clinical trials Phase II started in 2016 in Europe with 44 patients, with a subsequent phase III planned in both Europe and North America. Immediate commercialisation will then follow market authorisations in these two regions.

In the long run, CellProthera’s therapeutic goal is to extend this cell therapy to regenerate other organs based on the same technology platform.

What are the next steps for the company in Singapore?

In Singapore, CellProthera is currently validating its industrial process to start a trial in 2018 on 10 patients to develop a clinical platform in Asia. This trial is carried out in partnership with the National Heart Centre Singapore (NHCS) and the HSA Cell Therapy Centre both located at Outram campus. The NHCS, referral regional centre for cardiovascular diseases, is in charge of stem cell injections within the heart muscle whereas the HSA Cell Therapy Centre, equipped with a clean room, is in charge of stem cells processing.

In Singapore, CellProthera is currently validating its industrial process to start a trial in 2018 on 10 patients.

 

 


CellProthera is a biotech company, incorporated in April 2008, and intended for the development, registration and marketing of innovative therapeutic solutions for the regeneration of organs damaged by disease or trauma from autologous blood peripheral stem cells. Find out more about CellProthera on the Smart Health platform.

Interview with Alexandre Civière, Project Manager, CellProthera

Published in FOCUS Magazine — Issue #3 2017 “In the Pink of Health”

 

 

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