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There are times in human history when quantum leaps occur in our thinking and approach towards the various issues we face as a race. The world of medicine and healthcare has witnessed one such landmark in the past decade. That is, the revolutionary field of cell therapy, which was awarded the prestigious Nobel Prize in Physiology or Medicine in the year 2012. This Nobel Prize was awarded jointly to British scientist Sir John B. Gurdon and Japanese stem cell researcher Shinya Yamanaka for the discovery that mature cells can be reprogrammed to become pluripotent.
Nobel Prizes in Stem Cell Research
Demonstration of stem cells in bone marrow
Isolation of embryonic stem cell in mice
Mature, specialized cells can be reprogrammed to become immature cells capable of developing into all tissues of the body
About Cell Therapy
Regenerative medicine is a game changing and rapidly evolving field of modern medicine. It is focused at repair, restoration and replacement of damaged tissues by a safe and effective administration of living cells either in solitude or in combination with specially engineered materials. Regenerative medicine itself isn’t new; the first bone marrow and organ transplants were carried out decades ago. Technological advances in developmental and cell biology, immunology, and other fields have ushered in a new era of therapeutic strategies to refine existing regenerative therapies and develop novel ones. These therapies are beneficial for a multitude of disorders that today, are beyond repair. This includes neurological disorders like autism, cerebral palsy, muscular dystrophy, spinal cord injury, brain stroke, traumatic brain injury, etc. Current research in the field of regenerative medicine utilize stem cells to create functional tissues to regenerate damaged or injured organs and tissues.
A cell is the basic structural and functional unit of all living organisms. Cells have evolved over billions of years and are responsible for all the metabolic activities of the body. They have adapted to a wide array of functional roles and environments. All cells originate or "stem" from simpler and premature cells that have not specialized or differentiated yet. These unspecialized cells are called stem cells. Stem cells are one of the building blocks of the ever evolving field of Regenerative Medicine. They have fascinated clinicians and scientists for over a century. They can be defined as undifferentiated cells that have the remarkable property of giving rise to different cell types. All multicellular organisms rely on stem cells to develop from a single cell to a fully mature adult. Stem cells are also responsible for replacing or replenishing specialized cells in the body that are damaged or worn out. Stem cells are now considered to be a miracle of modern medicine and have given rise to a new era of therapeutic strategies. A variety of stem cells are being used from diverse sources or origins.
Stem cells are characterized by two unique and distinct properties of self renewal and differentiation into various cell types. They have the remarkable potential to divide indefinitely, producing a population of identical cells. Additionally, in many tissues they serve as a sort of internal repair mechanism, dividing essentially without limitations to replenish other cells. Stem cells achieve their reparative functions through the following mechanisms:
They release or facilitate the release of growth factors which have a regenerative and healing effect on damaged tissue.
They promote angiogenesis or increase the blood supply to the damaged tissue thereby aiding in the repair process.
Furthermore, once transplanted, they have the unique ability of transforming into the specific cell types of that tissue.
A) They can Multiply infinitely
B) Stem cells can convert themselves into other cell types
C) Stem cells release positive chemicals
D) Stem cells improve blood supply
Based on their origin, stem cells can be broadly classified into the following three categories:
Embryonic Stem Cells - These cells are derived from the inner mass of the 5 to 7 day blastocyst. They are usually obtained from IVF clinics. These are the most potent type of stem cells, but come with a flipside of being associated with a myriad of ethical and legal issues.
Umbilical Cord Stem Cells - These type of stem cells originate from the umbilical cord and are obtained immediately after birth. Umbilical cord blood is rich in stem cells and also other cellular components like immune cells which have remarkable benefits. These cells are now stored and preserved by Cord Blood Banks for future use.
Adult Stem Cells - Stem cells have been identified in most organs of the human body including the bone marrow, brain, peripheral blood, skeletal muscle, skin, teeth, heart, liver, gut, ovarian epithelial tissue and testis. It is believed that they reside in a specific area of each tissue called a "stem cell niche". The primary role of these adult stem cells is to initiate reparative mechanisms following organ damage or injury. These cells are associated with the least ethical issues and are therefore, being used for cell based therapies for a variety of disorders.
The word potency is taken from the Latin term "potens" which means "having power". The capacity or "power" of stem cells to differentiate into specialized cell types and further give rise to any mature cell type is called potency. Based on their potency, there exists a hierarchy in the stem cell compartment.
Totipotent Stem Cells: These stem cells, also called omnipotent stem cells, are produced from the fusion of an egg and sperm cell. They have the ability to differentiate into embryonic and extraembryonic cell types, and can construct a complete, viable organism. Cells produced by the first few divisions of the fertilized egg are also totipotent.
Pluripotent Stem Cells: These are the descendants of totipotent cells and have the potential to differentiate into nearly all cell types, i.e. cells derived from any of the three germ layers (ectoderm, mesoderm and endoderm). Embryonic stem cells are categorized as pluripotent.
Multipotent Stem Cells: These cells can differentiate into a limited number of cell types. They can give rise to cells of one of the germ layers only. Sources of multipotent stem cells range from 8 day old embryos to adult bone marrow.
Unipotent or Monopotent Stem Cells: These stem cells are tissue committed and give rise to cells of one lineage. For example, hematopoietic stem cells, epidermal stem cells, intestinal epithelium cells, neural stem cells, etc.
At NeuroGen, we utilize adult stem cells obtained from the patient’s own body to treat incurable disorders like Autism, Cerebral Palsy, Muscular Dystrophy, Mental Retardation, Spinal Cord Injury, Traumatic Brain Injury, Ataxia’s, etc. We offer a unique and holistic combination of cell therapy and neurorehabilitation in our treatment program. We believe that a multidisciplinary approach is the key to not only treat patients with these conditions, but to also restore health and vitality.
The cell therapy we provide is minimally invasive, effective, requires no major surgery or incision and is 100% safe, since it utilizes autologous adult stem cells. Our neurorehabilitation techniques involve an intensive regime, administered by experienced professionals from various fields which including physiotherapy, occupational therapy, speech therapy, special education, psychology, etc. All these facilities are housed within our eleven storeyed multispecialty centre, along with provisions for special consultations.
The rationale for using Adult Autologous Stem cells, as opposed to umbilical cord cells is as follows:
Autologous Stem cells mean, that the cells are extracted the from the patient’s own body, which means, that the chance for bodily rejection is negated.
Since the cells are extracted on the same day as the injection, there is no need for culturing the cells, and injecting them in small doses. The cells can be injected once directly.
The use of the patient’s own cells also substantially reduce the chances of any untoward side-effects.
Unlike umbilical cord cells, which are stored in a cryogenic fluid, which may affect the cell membrane, thus even affecting the quality of cells, and making them unusable to be injected intrathecally, adult autologous bone marrow-derived stem cells are not stored in any chemical and neither are they processed through any other chemical, which makes them safe for use intrathecally.
The rationale of injecting the stem cells intrathecally (into the spinal fluid of the patient):
The source of neurological conditions are the brain and nerves, which branch through the spine. Hence, injecting the cells through the spinal fluid, is the safest and most direct source of ensuring that the cells are reaching the nervous system. Injecting the cells intravenously (through the vein) for neurological conditions is counter-productive, as these cells would essentially be travelling all over the body, and the number of cells to reach the brain cannot be accounted for. These cells may also face the blood-brain barrier, and thus, may not reach the brain in adequate quantities.
The procedure is carried in the following three steps:
Bone Marrow Aspiration:
Bone marrow is the soft spongelike material found inside the bones. The formation of blood takes place within the bone marrow. The bone marrow is considered as a rich source of adult stem cells. The iliac or hip bone is the easiest source for the extraction of bone marrow derived stem cells. This extraction is carried out with the help of a bone marrow aspiration needle. The procedure is usually carried out under local anaesthesia. For children and adults who cannot tolerate the procedure, sedation or general anaesthesia may be administered as required. This procedure takes only 15 to 30 minutes. Around 80 ml to 120 ml of bone marrow is aspirated, depending on the weight of the patient. After this, the patient is sent back to their room to rest for the next step.
Separation of Stem Cells:
The bone marrow aspirate is then transferred to the stem cell laboratory for processing. This is a fully equipped GLP (Good Lab Practice) & GMP (Good Medical Practice) certified laboratory, where the density gradient centrifugation method is utilized to separate or isolate the stem cells from the aspirate. This method takes advantage of the differences in density between the various varieties of cells found in the aspirate and the density gradient medium (the reagent used for separation). The method separates the Bone Marrow Mononuclear Cells (BM MNCs). BM MNCs are a heterogeneous mixture of cells which include hematopoietic (lymphocytes, monocytes, stem cells and progenitor cells) and non-hematopoietic cells (mesenchymal stromal cells, endothelial progenitor cells - EPCs, etc.). The separated fraction of BM MNCs appears as a cloudy layer called the "buffy coat". The separation process takes around 3 to 5 hours.
Stem Cell Injection:
Once the BM MNCs are separated and purified (about 3-4 hours), the patient is taken back to the operation theatre. The stem cells are first diluted in the cerebrospinal fluid (CSF) and administered intrathecally (injected into the fluid around the brain and spine) using a spinal needle. In certain cases, where stem cells are to be injected into the muscles (eg. Muscular Dystrophy patients - as assessed and recommended by the rehabilitation team) these cells are diluted in the CSF and then injected into the muscles using a very thin needle.
The stem cells are injected with the help of a spinal needle in the spinal canal through a lumbar puncture. This is the intrathecal route of administration and it helps in overcoming the blood brain barrier. The lumbar puncture helps the stem cells to migrate directly to the damaged brain areas and regenerate neurons. As opposed to this, cells injected intravenously, must go through various organs such as liver, lung, etc. Due to this, the number of cells finally reaching the target area would be far less than required.
Adult stem cells are available in abundance and can also be isolated easily.
The use of adult stem cells does not involve side effects.
Cell therapies utilizing adult stem cells are safe and efficacious.
They are isolated from the patient’s own body (referred to autologous stem cells), which overcomes the problems of immunological rejection.
Adult stem cells have the potential of replenishing many specialized cells from just a few unspecialized ones.
They are not associated with any ethical or moral issues, as they do not involve the use of embryos.
They also do not pose the risk of tumor formation as compared to other types of stem cells.
The cell therapy at NeuroGen is followed by an intensive neurorehabilitation process which includes physiotherapy, occupational therapy, aquatic therapy, creative visualization, yoga therapy, counseling and specialized diets. (We strongly emphasize that cell therapy should be followed by a proper rehabilitation regime to gain a proper response. The rehabilitation therapies enable the mobilization of stem cells and aid in the regenerative and reparative process. This holistic approach helps the patients to lead a better quality of life and contributes to their overall wellbeing.Our entire treatment program of cell therapy combined with neurorehabilitation is referred to as Neuro Regenerative Rehabilitation Therapy (NRRT).
Adult autologous bone marrow-derived cell therapy is a completely safe form of treatment. At Neurogen BSI and in all the available publications internationally and nationally, there have been no cases of serious adverse events or neurological deterioration due to cell therapy. Minor reversible symptomatic procedure related problems occasionally do occur but these are completely treatable with no long lasting effects.
Rapid progress in the field of biotechnology has introduced a myriad of pressing ethical issues associated with stem cell research. Worldwide and particularly in Asian countries, where cell therapy is more advanced, the ethical basis of utilizing cell therapy as a treatment modality is based on the Declaration of Helsinki (DoH) on the ethical principles for medical research involving human subjects. This Declaration of Helsinki is a set of ethical principles regarding human experimentation developed for the medical fraternity and is drafted by the World Medical Association (WMA). It is widely regarded as the cornerstone document on the bioethics of human research. The following is an excerpt from the Declaration of Helsinki:
"In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorised representative, may use an unproven intervention if in the physician's judgement it offers hope of saving life, reestablishing health or alleviating suffering. This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information must be recorded and, where appropriate, made publicly available."
Hence, as per the Declaration of Helsinki, cell therapy can be utilized for conditions which have no other treatments available. At NeuroGen Brain and Spine Institute, we strictly adhere to and abide by the above stated Declaration.