India may host a trial to test so-called artificial blood, or blood substitutes, later this year, a first for a country that is increasingly becoming home to all sorts of human clinical trials.
Arthur Bollon, chief executive of HemoBioTech Inc., a small firm based in Dallas, Texas, said the India trials of HemoTech, the brand name of the product, will run simultaneously with tests in the US and be a crucial step in giving the world the first viable substitute for human blood.
HemoBioTech, founded in 2001, trades on the Over The Counter Bulletin Board in the US and last traded at $1.26 (about Rs50) a share. The technology, it says, has been licensed from the Texas Tech University Health Science Centre in Lubbock
“We have appointed Paragon Biomedical Inc. to carry out trials in India and the US, and we hope permission to begin phase I trials in India will come by later this year,” he said. “We conducted a limited trial in Zaire on nine sickle-cell anaemia patients in (1991) and found that it was non-toxic. Injections with significant amounts—25% of total blood volume—have found that it was safe.”
The India office of the California-based Paragon Biomedical is located in Thiruvananthapuram in Kerala. A company executive, Vinod Narayanan, confirmed the trials, but declined to elaborate.
In a telephone interview, Bollon declined to discuss details on the number of patients who might be involved in the trial, but added that the target population was those suffering from “acute anaemia, trauma patients and those requiring angioplasty”.
The benefits of a wide genetic pool and cheap costs of testing new products, are some of the reasons why international drug companies are choosing India for conducting their clinical trials.
“While we are focused on establishing a US clinical trial of HemoTech, in addition, HemoBioTech considers India to be an integral part of our global strategy to commercialize HemoTech,” claimed Bollon.
Policymakers say that though the potential for clinical research was indisputable in India, a still-evolving set of medical guidelines could also open the field to misuse of the population. “The clinical registry is already in place, where companies must publicly make available details of their trials,” said an Indian Council of Medical Research (ICMR) scientist who is involved with ICMR’s ethics body. “Though it’s still voluntary, unless companies register on it, it will be tough to track implementation of clinical trial procedures on the ground.”
Though referred to as artificial blood, scientists still don’t expect blood substitutes to completely replace human blood even as many companies have tried to perfect the product over many decades.
“The basic aim of a blood transfusion is to just have a non-infectious way to temporarily administer oxygen to every tissue when there’s acute blood loss (more than 40% of the total volume) or somebody is anaemic,” said Kanjaksha Ghosh, director of ICMR’s Institute of Immunohaemetology, Mumbai.
After centuries of failed experiments ranging from injected animal milk to synthetic chemicals called perofluorocarbons (PFC, also used in non-stick pans), an overwhelming number of scientists believe that the future lies in mimicking haemoglobin. They are tiny molecules, trapped in red blood cells produced in the bone marrow, that perform this vital oxygen-carrying role; from the lungs where oxygen is produced to the remaining body tissues.
But merely injecting free haemoglobin (outside the cell) may fatally damage the kidney or destroy the blood vessels. “That’s the single biggest problem with haemoglobin, and containing it is the primary reason why most such attempts at creating blood substitutes fail,” said M.S. Valiathan, a cardiovascular surgeon and director of the Manipal Academy of Higher Education.
All haemoglobin, irrespective of whether it is produced in humans or animals, perform the same oxygen-transport function, even though they might not resemble their human counterparts.
Thus, HemoBioTech has taken cow blood, isolated the haemoglobin, and chemically modified it with three chemicals—adenosine triphosphate, adenosine and reduced glutathione. The three chemicals that prevent the haemoglobin from disintegrating and thus forming the toxic chemicals that damage the kidney.
HemoBioTech faces several competitors. A similar product called Hemopure is already approved for use in South Africa, and Hemolink, Hemospan and Optra, being tested by companies out of the US and Canada, are in different phases of trials.
“Irrespective of the level of phase trials, there’s no guarantee that even if such substitutes are approved they will be lapped up in the market. There are just too many aspects of blood that are poorly understood,” said Ghosh.
GreenCross, a blood substitute using PFC technology made by Japan’s Green Cross Corp., received US food and drug administration approval in 1989, but the firm discontinued the process in 1994 citing increased costs of producing and storing it
HemoTech can be stored for six months at 4 degrees Celsius, claimed Bollon, as opposed to regular blood that can’t make it beyond 42 days.
“If it lives up to its claims,” said Ghosh, “it could be most vital in trauma cases and probably in war zones. But if people merely donated enough blood, we wouldn’t need to develop such substitutes.”