Corporate Banner
Satellite Banner
Stem Cells, Cellular Therapy & Biobanking
>
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

C3BS Receives Authorization from Belgian FAMHP

Published: Friday, November 23, 2012
Last Updated: Friday, November 23, 2012
Bookmark and Share
Company to begin world’s first phase III clinical trial in regenerative medicine for heart failure.

Cardio3 BioSciences (C3BS) has announced that it has received authorization from the Belgian Federal Agency for Medicines and Health Products (FAMHP) to begin its Congestive Heart failure Cardiopoietic Regenerative Therapy (CHART-1) European Phase III trial for C3BS-CQR-1 in Belgium.

This represents a world premiere for a regenerative medicine product targeting heart failure to be tested in the context of a Phase III trial. C3BS-CQR-1 is an autologous stem cell therapy for heart failure.

The Phase III trial is a prospective, multi-centre, randomized, sham-controlled, patient-and evaluator-blinded study comparing treatment with C3BS-CQR-1 to a sham treatment.

The trial will recruit a minimum of 240 patients with chronic advanced symptomatic heart failure.

The primary endpoint of the trial is a composite endpoint including mortality, morbidity, quality of life, Six Minute Walk Test and left ventricular structure and function at 9 months post-procedure.

Studies in additional countries will commence once national regulatory approvals have been received.

The Cardio3 BioSciences therapy, called C3BS-CQR-1, involves taking stem cells from a patient’s own bone marrow and through a proprietary process called Cardiopoiesis, re-programming those cells so that they go onto becoming heart cells.

The cells, known as cardiopoietic cells, are then injected back into the patient’s heart through a minimally invasive procedure using a catheter called C-Cathez®, with the aim of repairing damaged tissue and improving heart function and patient clinical outcomes.

C3BS-CQR-1 is the outcome of multiple years of research conducted at Mayo Clinic (Rochester, Minnesota, USA), Cardio3 BioSciences (Mont-Saint-Guibert, Belgium) and Cardiovascular Centre in Aalst (Aalst, Belgium).

This Phase III trial builds on the successful outcome of the Phase II trial conducted between 2009 and 2010 in multiple clinical sites in Belgium, Serbia and Switzerland.

Dr Christian Homsy, CEO of Cardio3 BioSciences, said: “Heart failure remains a significant unmet clinical need associated with high morbidity, mortality and escalating healthcare costs. We believe C3BS-CQR-1 has a potential to become an alternative to heart transplantation which is the only curative treatment for heart failure available today. Our Phase III trial is the first to begin anywhere in the world for a regenerative therapy for this indication. We look forward to confirming the promising results we have already seen in our Phase II study.”

Dr Jozef Bartunek, Principal Investigator, added: “Regenerative therapies have the potential to revolutionize the treatment of heart disease and other conditions and we are excited to be working with Cardio3 BioSciences on what is a ground breaking study. The results seen in the earlier trials were encouraging and if repeated in this larger study would bring nearer a potentially disruptive treatment for the expanding epidemic of heart failure.”

Cardio3 BioSciences has completed a Phase II trial with C3BS-CQR-1, which demonstrated that heart failure patients improved heart function and exercise capacity following treatment compared to patients receiving current standard of care.

Moreover, feasibility and safety of the C3BS-CQR-1 treatment regimen were established.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,900+ scientific posters on ePosters
  • More than 4,200+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

C3BS Raises €19 Million Through a Private Placement
New funds will be used to finance the on-going clinical development of C-Cure®.
Tuesday, July 09, 2013
Results from C3BS C-CURE® Trial Published in the Journal of the ACC
Trial demonstrates statistically significant improvements in heart function and exercise tolerance with cardiopoietic stem cell therapy.
Monday, April 15, 2013
Cardio3 BioSciences Announces Significant Progress in its Programme for the Treatment of Acute Myocardial Infarction
The Belgian biotechnology company, Cardio3 BioSciences, a leader in the discovery and development of regenerative and protective therapies for the treatment of cardiovascular diseases, have announced positive pre-clinical results from its in-house product candidate C3BS-GQR-1, a “cardiopoietic” cocktail designed to treat patients suffering from acute myocardial infarction in order to protect cardiac tissue from damage and direct heart stem cells to mature and restore pump function.
Friday, December 24, 2010
Scientific News
Bile Acid Supports Production of Blood Stem Cells
A research group at Lund University has been able to show that bile acid is transferred from the mother to the foetus via the placenta to enable the foetus to produce blood stem cells.
New Biomarker to Assess Stem Cells Developed
A research team led by scientists from UCL have found a way to assess the viability of 'manufactured' stem cells known as induced pluripotent stem cells (iPSCs). The team's discovery offers a new way to fast-track screening methods used in stem cell research.
Tricked-Out Immune Cells Could Attack Cancer
New cell-engineering technique may lead to precision immunotherapies.
Edited Stem Cells Offer Hope of Precision Therapy for Blindness
Findings raise the possibility of treating blinding eye diseases using a patient's own corrected cells as replacement tissue.
Hacking the Programs of Cancer Stem Cells
All tumor cells are the offspring of a single, aberrant cell, but they are not all alike.
Newfound Strength in Regenerative Medicine
A promising new approach uses direct mechanical stimulation to repair severely damaged skeletal muscles.
Mapping out Cell Conversion
Researchers develop algorithm that takes the field of cell reprogramming forward.
Donor's Genotype Controls the Differentiation of IPS Cells
Pluripotent stem cells derived from different cell types are equally susceptible to reprogramming, indicates a recent study by the University of Helsinki and the National Institute for Health and Welfare, Finland. However, the genotype of the donor strongly influences the differentiation of the stem cell.
Signals That Make Early Stem Cells Identified
Researchers at The Rockefeller University have identified a new mechanism by which cells are instructed during development to become stem cells
Healing Scarred Hearts
Findings suggest stem cells may one day be used to regenerate damaged tissue after heart attack.
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,900+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,200+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!