International Stemcell Services Limited (ISSL), a therapy major, has commenced its clinical trials on autologous dendritic cell vaccine. The study is carried out on cancer patients with solid tumours which can be operated.
There are five patients signed up for the trial and these patients have been found to have the solid tumour, localized at a primary site. Since this is an autologous procedure where the patient’s own dendritic cells are used, the clinical trial is approved by the Institutional Committee for Stem Cell Research and Therapy (ICSCRT) and the Independent Ethics Committee. The major criterion for clearances is informed patient consent, Dr Gururaj A Rao, research director, ISSL, told Pharmabiz.
The human study’s success so far has indicated that it is opening up promising opportunities for stem cell companies and healthcare majors with an independent cancer care centre or dedicated oncology hospitals to identify patients for this procedure, he added.
The dendritic cell vaccine therapy is prescribed as a prevention to the onset of the tumours which have been operated. From the tumour biopsy, a tumour peptide is derived. The patient is slotted for bone marrow aspiration and then sent in for conventional treatments like chemotherapy and radiation. Once the tumour burden is under control, it is a phase of immune suppression following radiation and chemotherapy, which is the ideal time to administer the vaccine, depending on the clinical prognosis.
The key objective of the clinical trial is to prevent metastatic relapse of solid tumor carried out after conventional approaches and used as a combinational therapy, he added.
Now the trend is towards customized cancer therapy using patients own stem cells derived from the tumour peptide. The dendritic cells are derived from the patient’s own bone marrow, he said.
Dendritic cell therapy is US FDA approved and hence a globally accepted procedure. Since the process is tailor-made, its scale-up is an issue. Therefore, going by the success of the vaccine so far, many hospitals and stem cell research companies now will partner to offer the therapy, pointed out Dr Rao.
While the major challenge is that this procedure is only dependant on the condition and location of the solid tumour which most of the time appears non operable. Such situations pose difficulty in obtaining the tumour peptide. But experts are viewing options to overcome the drawback with access of chemically synthesized peptide rather than depending on biological samples, said Dr Rao.
“This is where government of India should provide grants to research labs in India to understand the structure of chemical peptides under the oncology therapy projects. This would help the medical scientists and drug researchers to study the entire repertoire of tumour peptides which could serve as a blueprint to medical investigators and oncologists. It would also help to overcome the dependence on biological samples and help mitigate the technical issues, stated Dr Rao.