At NeuroGen, we utilize adult cell 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 regenerative medicine and neurorehabilitation in our treatment program. We believe that a multi disciplinary approach is the key to not only treat patients with these conditions, but to also restore health and vitality.

The regenerative medicine we provide is minimally invasive, effective, requires no major surgery or incision and is 100% safe, since it utilizes autologous adult cell. 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 bone marrow cells, as opposed to umbilical cord cells is as follows:

• Autologous bone marrow 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 mononuclear 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 autologous bone marrow derived mononuclear 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:

1. Bone Marrow Aspiration:

   Bone marrow is the soft sponge like 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 cell. The iliac or hip bone is the easiest source for the extraction of bone marrow derived cell. 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.

   

2. Separation of Cell:

   The bone marrow aspirate is then transferred to the 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 cell 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, cell 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.

   

3. Cell Injection:

   Once the BM MNCs are separated and purified (about 3-4 hours), the patient is taken back to the operation theatre. The cell 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 cell 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 regenerative medicine 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 regenerative medicine should be followed by a proper rehabilitation regime to gain a proper response. The rehabilitation therapies enable the mobilization of cell 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 regenerative medicine combined with neurorehabilitation is referred to as Neuro Regenerative Rehabilitation Therapy (NRRT).

Global Perspective

Rapid progress in the field of biotechnology has introduced a myriad of pressing ethical issues associated with cell research. Worldwide and particularly in Asian countries, where regenerative medicine is more advanced, the ethical basis of utilizing regenerative medicine 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, regenerative medicine 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.