CARDIOGENEA™

Mesenchymal stem cells derived Cardiopoietic Autologous Treatment for patients with Acute Myocardial Infarction.( autologous Cardiopoietic living cell transplant for the treatment of Heart failure.

The procedure consists of the followings Standard Operating Procedures:

Collection:

Human bone marrow was harvested from the iliac crest with quality control ensuring temperature control and sterility of KIT during transportation between sites of collection and manufacturing.The ΚΙΤ is marked with a unique barcode, so that a continuous traceability exists and includes all the relevant documents that must be filled by the donor. The collection KIT is transferred immediately to the laboratories of Biogenea Pharmaceuticals Ltd for further processing.

Processing:

Immediately after the arrival of the collection KIT at the laboratories of the company, it is unpacked and processed in a sterile environment under GMP conditions. The whole process is carried out directly with validated protocols according to the international regulations and specifications. ...

Immediately after the arrival of the collection KIT at the laboratories of the company, it is unpacked and processed in a sterile environment under GMP conditions. The whole process is carried out directly with validated protocols according to the international regulations and specifications. The final product can either be administered immediately after ex-vivo cell expansion bioreactors or can be frozen and cryopreserved for future use.

read more

Quality Control:

Each and every processing step is fully monitored. An inconsiderable amount of the preserved final product is stored extra and thawed after a couple of days in order to control the viability of the corresponding cryopreserved sample. Fully automated system has the advantage that its protocols ...

Each and every processing step is fully monitored. An inconsiderable amount of the preserved final product is stored extra and thawed after a couple of days in order to control the viability of the corresponding cryopreserved sample. Fully automated system has the advantage that its protocols are validated and the produced results are controlled and reproducible. Each collected sample undergoes full microbiological and genetic control. The microbiological control includes liquid culture in aerobic and anaerobic conditions using the automatic system. When a contamination is found in a sample, identification follows through an antibiogram. RealTime PCR is used to verify and identify the pathogen that is possibly detected in the serum of the sample.

read more

Long term Cryopreservation & Product Release:

Only after the completion of all the quality tests isolated Hematopoietic stem cells are stored in temperatures reaching the -196C ( in these conditions all the metabolic procedures are stopped ) and document/certificate of cryopreservation is issued.

Only after the completion of all the quality tests isolated Hematopoietic stem cells are stored in temperatures reaching the -196C ( in these conditions all the metabolic procedures are stopped ) and document/certificate of cryopreservation is issued.

read more

Clinical Indications:

Cardiogenea is released only according to hospital exemption procedure (1394/2007 E.C) to for patients with Acute Myocardial Infarction, and patients with Heart Failure. )