To manufacture a single course of DENVAX the following steps are taken:
To manufacture a six doses of Dendritic cell cancer vaccine (DENVAXTM), a fresh sample of peripheral blood (120 ml in amount as per the TLC count) of the patient is collected in CellNuteTM medium provided by ICT Lab Services.
The day blood is drawn is considered ‘Day 1’ of the protocol.
Peripheral blood mononuclear (CD14+) cells are isolated and cultured in cytokines along with the desired nutritional media.
These cells transform into ‘immature’ dendritic cells. For maturation, these cells are exposed to cancerous antigen on Day 6 of blood drawl.
Exposure of DC to cancerous antigen leads to maturation of dendritic cells, ready for infusion into the patient, on day 8.
The mature dendritic cells harvested on day 8 are re-infused into the same patient, intravenously as infusion. The Denvax infusion is repeated between 10-20 days interval and six doses are given in 2-4 months. All the doses are stored in our Liquid Nitrogen Storage facility and we send one dose across by air cargo and packed in dry ice to preserve the quality of cells.
Desirbale to have patients own Cancerous antigens for laboratory investigation. These are the bits of protein to understand the nature of antigen(s). This cancerous antigen may be extracted from either source:
a) The patient’s wax embedded tissue: tumor tissue preserved in wax for biopsy examination for further studies;
b) Formalin fixed tissue: patient’s tumor tissue preserved in formalin at the time of surgery for further studies;
c) Fresh FNA tissue: fresh sample of tumor tissue derived from Fine Needle Aspiration
You may Download the
ICT LEAFLET for additional information
on how to manufacture DENVAX.
DENVAX THERAPY IN ADVANCED STAGE CANCERS MEETS RECIST CRITERIA
As we know cancer treatment in advanced stages does not guarantee cure. Chemotherapy given to terminally sick patients fails to deliver any good and most of the times proves devastating and deadly.
Our experience with DENVAX in these patients has resulted in betterment in quality life and improvement in life span. However, the desired results of decreasing the tumor mass was very rare. To effectively prove that dendritic cell therapy works and meets RECIST criteria (Response evaluation criteria in solid tumors showing the decrease in size of tumor based on radiological evidence) has been a challenge for all immunologists.
Our recent introduction of some additional drugs along with Denvax has improvised the response. These patients are responding with Denvax in there terminal stages and meeting RECIST criteria requirements also. This finding shall go a long way in directly proving the efficacy of Denvax protocol in terminally sick patients and giving them a chance to live a normal life when ‘everyone’ has given them ‘death’ warrant.
To know more please send your emails and your willingness to become part of this protocol at firstname.lastname@example.org