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Dr Henrik Sillesen (Copenhagen, Denmark). This issue has been controversial for many years, and in our part of the world, this is not an option. We just heard from Australia that they are working on the Tamaris project, which is just another option of treatment for these patients who cannot be reconstructed. Would it be possible to do a double-blind trial? I can easily imagine some problems with how to have a placebo injection, but would it be possible?

Dr Vishnu Motukuru. That would be tough. The TAG study was published, we have the first part of the study; it was a double-blind plan in which one group had saline injected and the other had stem cells injected. But in the immune setup, it is not going to be easy. The second thing you need to bear in mind is the whole cost of this procedure, it is probably around $200 to $300, and even this had to be funded in total.

Dr Krish Soundararajan (Philadelphia, Pa). In an era where surgeons seek invasive therapy, it is refreshing to see your work on nonsurgical management of critical limb ischemia. I have two questions. The first one is would the stem cell therapy have any different outcome if you had applied it in ischemia due to atherosclerosis rather than Buerger's disease? Is there any reason why you chose to confine the therapy to Buerger's disease?

The second question is with regards to the cost factor and my understanding that many patients in India may not be able to afford therapies to improve lifestyle in occlusive disease. How do you see stem cell therapy helping an average laborer in India? Would this be a technology which is beyond their means?

Dr Motukuru. Firstly, it is still quite controversial. So we just wanted to apply this, because it is being done for the first time in India, so we wanted to play safe. So that is the reason we excluded diabetics and we offered this only to patients in whom nothing else is possible. Probably in our older patients and patients with atherosclerosis, there are other alternatives which can be tried. But this was offered only to a specific subset of nonclassical Buerger's in whom everything else has been tried. So that is the reason we specifically selected this subset wherein there is no option at all other than an amputation.

Dr Soundararajan. Does that mean if you had a patient with ischemia due to atherosclerosis who did not have any other options you would have included them in this study?

Dr Motukuru. I doubt it, because we were basically looking at people who are young, who are extremely healthy, and who could probably tolerate any complication. So a person with advanced atherosclerosis, your morbidity/mortality would go up given the nature of the disease.

Dr Chris Liapis (Athens, Greece). Most of the times patients with Buerger's disease have lesions in the distal arteries, like digital arteries. Why do you think that injecting the calf area is going to improve the situation in the obstructed distal arteries?

Dr Motukuru. Because this was the first series, we injected all the patients into the calf muscles. But the last five cases, we were also injecting the stem cells into the foot. But because we don't have a 6-month follow-up, I haven't presented those.

Dr Enrico Ascher (Brooklyn, NY). I know of at least three stem cell studies investigating the potential for limb salvage. In our study we agreed to inject the stem cells along the course of tibial vessels. Do you think that this method better promotes angiogenesis?

Dr Motukuru. I am not aware of it, sir. But we started injecting in the foot. But as far as the results are concerned, I have no idea.

Dr Gregorio Sicard (St. Louis, Mo). These patients, obviously, all of them are very heavy smokers. And did you look, even though it is a small number of patients, how many of these patients continued their smoking habits? Because I think that is going to muddy the results.

And the second question, one of the therapies that is being looked at, obviously, in multiple institutions across the world, is rather than obtaining the stem cells from the bone marrow is to use granulocyte stimulation factors or certain factors that promote the recruitment of stem cells from the bone marrow to the site of the ischemia. Have you looked at that in India?

Dr Motukuru. We haven't, sir, because there were a couple of papers which said granulocyte-stimulated factors helped, but then there were a couple of papers that said it doesn't help. And secondly, one of the limitations of the study was we did give them a strong counseling, but we did not do urine creatinine assay levels to really assess whether they were actually smoking or not smoking; and hence, we couldn't really assess the impact of our counseling on the results, purely because of financial constraints.