Chennai: The Xenograft project of Frontier Mediville using bovine heart valves to correct defective human valves has hit a roadblock with the Centre seeking a comparative study on this innovation for granting approval.
Furthermore, lack of fiscal support for the key project at India’s first bioscience research park is delaying even more this biological prosthetic valve project, which saw scores of patients successfully undergo the phase III clinical trial.
In November last year, a two-year-old boy from Bahrain successfully underwent a heart surgery and the Chennai based cardio surgeon Dr K. M. Cherian, in a rare combination of skills and technological innovation, corrected the infant's abnormal connection and saved his life by using three types of tubes - Homograft (human tissue), partly by Xenograft (jugular vein taken from buffaloes) and partly with Dacron (polyester).
Research at the sprawling 360-acre bio-village, Frontier Mediville, located on the National Highway No. 5, at Elavur Village, Tiruvallur district, (about 40 km from here) has perfected the technology of creating biological heart valves from pigs or bovines' valves and found these valves are effective, less expensive and long-lasting compared to the mechanical valves, which are currently being imported.
These valves obtained from the pigs or bovines are decellularized (i.e. the process of removing all the cells of the animal graft and leaving an extracellular matrix scaffold of the original tissue), so as to minimise the chances of rejection by the human system.
The institute, which took up the research under the direct supervision of Dr Cherian, chairman, Frontier LIfeline hospital, applied for recognition to the Indian Council of Medical Research for this innovation.
“We are finding it difficult to commercialise the Bio-Prosthetic Valves (BPV), though we successfully did an immunological study. The Hanover University, which tested the immune response of seven patients where Xenograft were used have testified that there has been no reaction. The first, second and third phases of use of biological valves have been completed and the project for commercialisation has been submitted to the authorities on Oct 20, 2015,” Dr Cherian says.
“The authorities asked all sorts of questions like what is the comparative study.
The ICMR, which commissions clinical trials, ought to know this kind of research on BPV has not been done anywhere. If this is allowed on a commercial scale, India will be the third country after US and Brazil, to have its own bio-prosthetic valves. We have even made representations to the Centre twice last year about things moving at a very slow pace at CSIR office,” he said.
