Indigenous Dendritic Cell Vaccine

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Regulatory Support and Clinical Trial Oversight for Indigenous Dendritic Cell Vaccine

This was a clinical trial project for an autologous Dendritic Cell (DC) Vaccine for the treatment of solid tumors in patients who had failed multiple chemotherapy and radiation therapy treatments and were only on palliative care. The subjects had a minimum life expectancy of 3months.

Nextvel was involved in the clinical trial management oversight and regulatory support for this project. This DC Vaccine was developed by an indigenous company. This was a very logistically challenging study. Subjects participating in the study had to go through the apheresis procedure at the sites post which their PBMCs (peripheral blood mononuclear cells) had to be transported in cold chain from 10 different trial sites across India to a central location for processing within 24 hours of its collection.

Once the vaccine was ready it had to be shipped back to the location of the trial sites for administering to the patients, again in cold chain. The six doses of the vaccines were administered weekly to the subjects.

This study was successfully completed in the given time and budget and the results were accepted by ESMO (European Society of Medical Oncologists) as a poster presentation. It received the Best Abstract Award at UAE Cancer Congress and was also present at the Korean Cancer Congress.

The study was published in Cytotherapy-The Journal of Cell Therapy by ISCT (International Society for Cell Therapy).

The product was granted commercial approval and since then has been on the market.