4. What is APCEDEN produced by APAC BIOTECH?
APCEDENŽis an autologous dendritic cell preparation manufactured by APAC biotech using the patient's PBMCs (peripheral blood mononuclear cells) extracted through the leukapheresis process. Since it is an autologous process Apceden prepared for a particular patient cannot be used by any other patient.
5.(a) What is Leukapheresis?
Leukapheresis is a process of collection of Peripheral blood Mononuclear cells through a cell separator. Through the circulation of blood the cells are collected and it takes approximately 2 hours to complete the process. It is a onetime process and the whole cycle of treatment is of six dose.
The cells collected from the patient are prepared in highly sophisticated lab with cleanest environment by highly trained scientist.
5.(b) Why is Leukopheresis required?
To prepare an effective dendritic cell formulation a good yield of Peripheral blood mononuclear cells are required, which can only be extracted through the leukapheresis process in a much more efficient way than the traditional method i.e. blood draw.
6. How many doses are prepared and what is the dose schedule?
Through the process of leukapheresis 6 doses of APCEDENŽ (Dendritic cell Therapy)are prepared which are given as first Dose on the 8th day of Leukapheresis and the subsequent 5 doses at two weeks of intervals of time.
7. At what stage of disease progression can a cancer patient opt for the therapy?
A cancer patient can opt for the therapy at any stage of disease progression although it is recommended that the therapy be taken when the disease load is minimal but APAC always follows the recommendation of treating oncologist.
8. Does a patient require a prescription from his/her treating physician?
Yes, it is mandatory for the patient to acquire a prescription for the therapy from his/her treating physician.
9. What types of cancers can be treated by DCT produced by APAC BIOTECH?
Currently APAC Biotech is treating all types of solid tumours.
10. Are there any contraindications to the therapy?
Immunologic testing can better establish the condition of the immune system to help physicians determine if a patient is a good candidate for Dendritic Cell therapy. Active autoimmune disease as well as pregnancy is possible contraindications. Contradictions should be carefully discussed and reviewed with the consulting physician before proceeding.
11. How is the dosage administered to the patient?
Dosage is administered through Intravenous infusion. The APCEDENŽ (Dendritic Cell Formulation) is suspended in 100 ml Normal saline solution which is then infused intravenously into the patient.
12. How is the APCEDENT dosage sent to outstation patients?
The prepared dose APCEDENŽ is shipped in a sealed viol at 40C-80C to the treating physician of the patient in a specialized insulated container. The dose is shipped along with the instructions for infusion and the materials required for the infusion. The dose has to be infused within 30 hours of dispatch.
13. Can the APCEDENŽ dose administered by the patient's treating physician?
Yes, the dose can be administered by the patient's treating physician.
14. Are there any side effects of the therapy?Is the dendritic cell therapy safe and effective?
As per trials there are near zero side effects. The only side effect seen in some patients is mild and fatigue. APAC BIOTECH had conducted a trial PAN India to prove the safety and efficacy of the Dendritic Cell Formulation (APCEDENŽ). During our clinical trials 225 infusions were given and most of the infusions were without any event except a single case where there was an episode of minor chills and fever.
15. What kind of benefits are seen in patients treated with Dedritic Cell (Immunotherapy)?
In the trial we can given a survival of 397 days to patients who had life expectancy not more than three months thus proving the effectively of the therapy.
16. Are there any dietary precautions to be taken before, after or during the therapy?
No, there is no such dietary precautions to be taken during the therapy but it is recommended to keep a healthy diet or as per the physician's prescription.