ARTHROGENEA™

Autologous bone marrow mononuclear cells (aut. BM-MNCs) for the treatment of osteoarthritis (OA).

The procedure consists of the followings Standard Operating Procedures:

Collection:

The bone marrow mononuclear cells are collected by orthopaedist in sterile environment according to a standarized arthroscopy procedure. (80 c.c bone marrow). The aut. BM-MNCs preparation consists of a heterogenous population of cells, including ...

The bone marrow mononuclear cells are collected by orthopaedist in sterile environment according to a standarized arthroscopy procedure. (80 c.c bone marrow). The aut. BM-MNCs preparation consists of a heterogenous population of cells, including MSCs, hematopoietic stem cells (HSCs), hematopoietic progenitor cells (HPCs), and endothelial progenitor cells (EPCs), adipocytes, macrophages, monocytes, neutrophils, and platelets. The aut. BM-MNCs migrate to target tissues and participate in repairing injured OA tissue.

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Processing:

The bone marrow sample is being coded with a unique barcode for its traceability both during the processing and after the release. Sample processing is being carried out immediately upon receive with validated procedures in a completely closed system ...

The bone marrow sample is being coded with a unique barcode for its traceability both during the processing and after the release. Sample processing is being carried out immediately upon receive with validated procedures in a completely closed system (biogenea® set). In particular, the aut-BM-MNCs are being isolated from bone marrow according to a centrifugation procedure. The whole procedure is being carried out in a laminar flow class A/B (Annex I - February 2008 EU guideline for the cGMP standards). There is a complete monitoring system inside the laminar flow 24h a day controlling the air as well as the germs.

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Quality Control:

An aut-BM-MNCs count is being performed both prior to and after the procedure. Prior to the procedure a functional aut-BM-MNCs count test is being performed. The aut-BM-MNCs analysis is carried out using the automated flow cytometry analyzer. After ...

An aut-BM-MNCs count is being performed both prior to and after the procedure. Prior to the procedure a functional aut-BM-MNCs count test is being performed. The aut-BM-MNCs analysis is carried out using the automated flow cytometry analyzer. After the procedure completion, a small amount of the final product is being used for the final numerical counting of the aut-BM-MNCs using flow cytometry SOPs protocol. A small amount of the sample is being cryopreserved and thawed especially for a viability test of aut-BM-MNCs after the cryopreservation procedure. Using this procedure we can guarantee that the viability of aut-BM-MNCs are intact during the cryopreservation. The viability test is being performed using the automated luminometric system, while the maturation test is being performed using a standarised protocol. A small amount of the stem cell culture is controlled for the presence of aerobic and anaerobic germs using the automated blood culture system, while in parallel the automated genetic analyzer is used for the detections of HBsAg, as well as for Hepatitis C, HIV Ι/ΙΙ , Toxoplasma , Syphilis and CMV.

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Long term Cryopreservation & Product Release:

Only after the completion of all the quality tests isolated aut-BM-MNCs 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 aut-BM-MNCs are stored in temperatures reaching the -196C ( in these conditions all the metabolic procedures are stopped ) and document/certificate of cryopreservation is issued. Product Release contains a quality certification:
Mean of 200 x 10.6 aut-BM-MNCs diluted in 5 ml PBS for intra-articularinfusion
Infusions: 1 therapeutic dose

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Clinical Indications:

ARTHROGENEA™ is released only according to hospital exemption procedure (1394/2007 E.C) to OA patients