We plan to bring out innovative tailor-made cells for diseases

Tag : mass flow controller

Stem cells are unspecialised cells that can self-renew indefinitelyand also differentiate into more mature specialised functionalcells. In some adult organs, stem cells can give rise to more thanone specialised cell type within that organ.
Can you gain anything from someone whose job has not beendetermined? In sports, the guy who sits on the bench can only sitand watch the game, till he is called for.
But we are in the 21st century and medical science can do wonders,breaking barriers and age-old thinking. So even though a stem cellis a cell whose job is yet not determined, new-age companies areopening new vistas of treatment with them.
Here’s the catch: Every single cell in our bodies‘stems’ from a stem cell. Like the Queen in chess, astem cell can become a lot of things, when it gets the signal. So,here you have a part of your body which can become a skin cell,bone cell, red blood cell, nerve cell, skeletal musclecell…thought not at the same time.
Stem cell company Stempeutics Research (backed by Manipal Education& Medical Group) is in the forefront of such innovation. Itssprightly President, Mr B. N. Manohar , in a luncheon interaction with Business Line , opened up a new world of therapy and possible cure for diseases,which conventional medicine cannot cure.
“The stem cells used in our experimental therapy areMesenchymal stem cells, which are derived from your own bonemarrow. These are multi-potent stem cells that can transform into avariety of cell types, and thereby help in regeneration and repairof the diseased tissues,” he told Business Line . Limited to bone marrow only? He clarifies. “While theinitial foray of Stempeutics is in bone-marrow-derived mesenchymalstem cells, Stempeutics is investing heavily in R&D to bringout some innovative products (like tailor-made progenitor cells) inthe near future based on adult stem cells.”
You were with Lucas TVS. What has pulled you in from electricalcomponents to this space?
Personally, my interest lies in handling “New”businesses where things are not defined properly. In the early partof my career I handled IT projects (Lucas-TVS/Wipro-GE). Then, Imoved from handling projects to managing production and logistics.The first business which I handled was the “ServiceBusiness” at Wipro-GE — with no prior experience ofhandling a service business. I could run it very successfully. Thisgave me confidence about myself. Then I ran healthcare IT businessat Wipro-GE, distance education business at Manipal — allwere started from scratch.
Stempeutics — was a co-incidence. MEMG (Manipal Education& Medical Group) was looking for a President for Stempeuticswith pharma/stem cell background. Seeing my track record (I thinkso) option was given to me to head Stempeutics. I did my homeworkfor 48 hours and then accepted the current post. It is really afascinating field. We can really transform medicine and offer newhope to millions of people.
Tell us what are stem cells?
Human body is made up of various cell types. There are about 210known distinct human cell types in the adult human body (examplesheart muscle cells, thyroid gland cells). A cell type is aspecialised functional form of cell.
Now, stem cells are unspecialised cells that can self-renewindefinitely and also differentiate into more mature specialisedfunctional cells. In humans, stem cells have been identified in theinner cell mass of the early embryo; in some tissues of the foetus,the umbilical cord and placenta; and in several adult organs. Insome adult organs, stem cells can give rise to more than onespecialised cell type within that organ.
Stem cells that are able to differentiate into cell types beyondthose of the tissue in which they normally reside are said toexhibit “plasticity”. When a stem cell is found to giverise to multiple tissue types associated with different organs, thestem cell is referred to as “multipotent”.
Broadly there are three types of stem cells depending from thesource of origin: Human Embryonic Stem Cells (HESCs), Fetal StemCells and Adult Stem Cells.
How does Stempeutics plan to leverage them?
Stempeutics is a stem cell company mainly focused on research,therapeutics and therapy in the field of regenerative medicine.Research at Stempeutics is directed towards acquiring the knowledgeand understanding of stem cells and its differentiation processrequired for the development of therapies to treat human diseases.
Stem cell research offers unprecedented opportunities fordeveloping new medical therapies for debilitating diseases and anew way to explore fundamental questions of biology.Stempeutics’ initial foray is to develop cell-basedtherapeutics using human adult mesenchymal stem cells derived frombone marrow. In future, it is planning to bring out innovativetailor-made cells for various diseases.
Currently, Stempeutics is focusing on the following diseases:Critical Limb Ischemia, Acute Myocardial Infarction, DilatedCardiomyopathy, Spinal Cord Injury, Parkinson’s Disease,Cerebral Stroke, Multiple Sclerosis, Diabetes-Type I, Musculardystrophy and Motor Neuron Disease.
Against conventional medicine which uses chemical entities orbiotechnology, how does stem cell therapy score?
Stem cell therapy aims at addressing the root cause of the diseaserather than the symptoms. For example, take Diabetes-Type 1. Stemcell therapy addresses how to regenerate the insulin producingcells and secrete them, whereas conventional medicine justaddresses only the insulin deficiency by injecting“insulin” medicine. But as on date, stem cell therapyis considered an experimental therapy. It is conducted as a pilotstudy.
Medical and scientific interest in stem cells is based on a desireto find a source of new, healthy tissue to treat diseased orinjured human organs. It is known that some organs, such as theskin and the liver, are adept at regenerating themselves whendamaged.
Recent research suggests that stem cells are a key to theseregenerative properties. We believe that stem cells would be amajor branch of medical treatment and would be a standard of cureand practice in the years to come.
Regenerative medicine is a rapidly emerging area of biomedicalresearch with enormous therapeutic potential, and this would be anideal supplement for existing medical treatments.
Isn’t stem cell business a fluid field?
No. It is not a fluid field. The basic fundamentals do not change;as our understanding of stem cells deepens, it opens up neweropportunities and avenues in therapies and the routes ofadministration. We also now understand the process of directeddifferentiation ( in vitro ) and are confident that this would only open newer horizons inregenerating hope for unmet medical needs.
Definitions change in a matter of months. Do treatments stay thesame, then?
Even though the definition changes, the treatment process remainsthe same. The regulatory process differs between autologous (refersgenerally to cells and tissues that are re-implanted in the sameindividual from whom they come) and allogenic (stem cells that aretaken from one person and given to another) treatment from countryto country.
There is controversy surrounding stem cells in the Western world.What is all that about?
Stem cell therapies raise many difficult and important ethicalissues and concerns. These are expected for any new approach or newtherapy involving human experimentation. The source of stem cell isa major ethical concern.
The use of embryos is generally not agreed upon especially whenfertilisation is performed for the sole use of stem cell research.For those who believe that the human embryo, even at the one-cellstage, has absolute moral value, equal to that of a new born babyor an adult, any embryo research is ethically unacceptable, as itwould tantamount to murder.
However the use of leftover embryos from in vitro fertilisation (IVF) techniques is legally allowed in manycountries. The embryos used in these cases were created forinfertility purposes through in vitro fertilisation procedures and when they were no longer needed forthat purpose, they were donated for research with the informedconsent of the donor.
There are no controversies on the usage of human adult stem cellsfor therapeutic purpose.
What about the costs? Are they in line with other hi-techtreatments? To what would you attribute the high cost: manpower,equipment, or technology?
Stem cell therapy costs are in line with other hi-tech treatments.Sometimes it may be cheaper. For example, Deep Brain Stimulation(DBS) used for Parkinson’s disease, or CardiacResynchronisation Therapy (CRT) used for Dilated Cardiomyopathy iscostlier compared to stem cell therapy. In general, stem celltherapy cost depends upon the type of stem cells used and also themode of treatment.
At Stempeutics we focus on bone-marrow-derived (from the patient)human mesenchymal stem cells. Human mesenchymal stem cells are 100per cent safe and can rapidly grow in culture without losing theirstemness. We have tied up with leading hospitals for stem celltherapy.
Hospitals charge the patients for the treatment. Stempeuticsprovides necessary services to the hospitals — like stemcells isolation and up-scaling in a clean room environment,extensive quality control checks, training and support in designingthe clinical protocols.
For charged patients, hospital charges work out to around Rs 3 lakhfor the entire treatment. This charge includes archival ofpatient’s mesenchymal stem cells for 10 years. The main coston the therapy is on stem cells up-scaling and quality control in a10K clean room environment and on the surgery for stem cellstransplantation.
Has Stempeutics been able to cure or improve conditions of apatient with stem cell treatment?
Yes. We are able to improve quality of life of many patients. Whilewe have seen 100 per cent safety, efficacy varies from patient topatient depending upon the disease type and disease status. We haveseen very good results in many diseases and also moderate to noimprovements in certain diseases.
Wherever we have seen moderate/no improvements we are reviewing ourclinical protocols with the experts to see how we can improve theefficacy. Sometimes we go back to bench and do further research onthe related stem cell science.
Outside India, there is a lot more happening on the stem cellstherapy part.
The global market for stem cell therapies is expected to be $20billion by 2010. Adult stem cell therapy currently dominates theglobal stem cells market with a share of almost 58 per cent. Thereare almost 30 prominent adult stem cell companies in the world.
Majority of the companies are based out of the US, followed by theEU; Israel, Thailand, Canada and Australia also have significantpresence of adult stem companies. Prominent stem cell companiesoutside India are Osiris, Organogenisis, Genzyme, Cytori, Aastrom,Theravitae, etc.
How are Indian companies faring in comparison to others outside?
India is lagging behind on research and clinical trials compared toother countries. Very few patents (less than 10) and no DrugController General of India (DCGI) approved clinical trials on stemcells!
Stempeutics is waiting for DCGI approval of two clinical trials.While the expected current stem cell therapy market in India isapproximately $540 million and expected to grow rapidly, there areonly a few dedicated companies focusing on real research andclinical trials.
Also, we believe the Government needs to be proactive in givingfast track approvals for clinical trials (like the FDA does in theUS) and allocate sufficient budget for stem cells research.
Stempeutics is supposed to be working on two medicines...
Stempeutics’ goal is to bring out stem cell based drug in thenear future using mesenchymal stem cells. Towards this goal,Stempeutics has submitted two proposals to the DCGI: One fortreating the heart — Acute Myocardial Infarction (also calledas heart attack) — and the other for treating the leg —Critical Limb Ischemia (CLI is a severe obstruction of the arterieswhich seriously decreases blood flow to the extremities and thenprogresses to the point of severe pain and even skin ulcers orsores).
We had several rounds of discussion with the DCGI and the IndianCouncil of Medical Research (ICMR). We hope to get the approvals inthe next three months. In case the trials are approved by DCGI, weexpect to bring out the medicine some time in 2010, and it will beavailable off the shelf.
At the same time, Stempeutics is also preparing to study morediseases for clinical trials in Malaysia. This project will beexecuted from Stempeutics Malaysia.
Do you think heavy expenditure makes stem cell therapy out ofreach? What should be done to make it more reasonable in terms of cost?
Stem cell business requires heavy investment. Investments increating a world-class lab for stem cell production, investments inR&D, animal studies, clinical trials, and so on.
But we believe that once we have an “allogenic” product— then the cost of treatment becomes very less and it will beaffordable by a common man.
Today the treatment is “autologous”. It takes about 4-5weeks to make the stem cells medicine ready for each patient in thelab and the cost associated with it is high.
But once we move towards “allogenic” — meaningthe stem cells originate from a healthy donor — we can uselarge scale production techniques. This reduces the production costand makes the therapy affordable. Stempeutics has the competency todo large-scale up-scaling. Stempeutics has patented the isolationand up-scaling process.
How has the support from the Government or regulators been to thisnew field?
The ICMR has prepared a draft of guidelines for stem cells researchand therapy. We are supposed to follow these guidelines. It has notbecome law so far. The draft guidelines await parliamentary nod.
As mentioned earlier, Government needs to create a separatetaskforce on stem cells research and therapy and see how India canleverage its intellectual talent and become a global leader in thisfield.
In Malaysia we are getting excellent support from the MalaysianBiotechnology Corporation. It provides seed, R&D and exportfunding for start-up companies (BioNexus status companies).
Also, it provides a 10-year tax sop from the year the companystarts making profit, duty exemptions and a host of other benefitsfor promoting stem cell companies.
We believe that the Indian Government should provide these benefitsto stem cell companies based on certain evaluation. Also as forstem cell clinical trials, the Government needs to think offast-track approval process considering it as “orphan”drug status — like what the FDA is doing in the US.
Tell us about your future outlook in this space in India. How doyou want to plan your company’s growth?
While the initial foray of Stempeutics is in bone-marrow-derivedmesenchymal stem cells, Stempeutics is investing heavily on itsR&D to bring out some innovative products (such as tailor-madeprogenitor cells) in the near future based on adult stem cells. Itis also investing money on its long-term goal of leveraging humanembryonic stem cells for therapeutics purpose.
Towards this goal four human embryonic stem cells lines have beenestablished. Also, Stempeutics is focusing on establishing a stemcell platform for drug screening and toxicity studies for thepharma companies. We want to become an undisputed leader in thestem cell area in this part of the world. We are also looking forstrategic partners, including acquisitions to accelerate ourgrowth.