Stem cell Research and Therapy

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Stem cell therapy

About Stem Cells Stem cell delivery methods Adverse reactions Rehabilitation Therapy disclaimer

About Stem Cells Most cells in the body have a specific function in particular organs, such as the liver, skin or brain. Stem cells are relatively undifferentiated and have the ability to develop into different types of cells to exert specialised functions. Among stem cell’s most notable characteristic is its ability to proliferate into a completely new, normal, and even younger cell. As a result, people can use their autologous or allogenic stem cells, or stem cell derived tissues or organs, to replace ill or aging tissues or organs, thus, enabling stem cell research as well as treatments for a wide range of diseases and injuries, many of which cannot be treated with traditional medical methods. For instance, stem cell therapy for diabetes is one of many such scenarios. In addition to proliferating new cells and providing cell replacement via stem cell science, an important function of mesenchymal or tissue stem cells is to provide the body with other cell factors in a paracrine manner. These cell factors help in the following functions:

Immune regulation

Decrease cell apoptosis (death)

Stimulate the differentiation of the patient’s own stem cells

Promote neoangiogenesis (the growth of blood vessels resulting in increased blood flow to damaged areas)

Reduce scarring

Improve the efficiency of intercellular electrical signals transduction

It is important to note that there is generally very little to no concern by informed or unbiased scientists about stem cells derived from cord blood, cord tissue or bone marrow, unlike embryonic/fetal stem cells. A growing number of international patients are seeking stem cell therapy in India. Researchers are currently finding ways to use adult stem cells to attack tumors, treat cancer patients and ailments like chronic obstructive pulmonary disease, ataxia, duchenne muscular dystrophy, multiple sclerosis and lupus among others. All batches of stem cells undergo final testing before they are packed for clinical application. During this process they are checked for potency by cell counting and viability assays. The purity of the stem cells is confirmed by differentiation assay, sterility testing and testing for the presence or absence of CD markers. The comprehensive quality control evaluation also includes assays for mycoplasma, endotoxins and karyotyping. Once the stem cells are deemed safe, each unit is considered fit to be released for therapy and stem cell transplants.
Stem Cell Delivery Methods The clinical staff at our partner hospitals for stem cell therapy in India utilise various methods for injecting the stem cells whether it’s for stem cell therapy for diabetes or some other ailment, including intravenous (IV), intrathecal (IT), intramuscular and intravascular interventional injection. A combination of the above methods ensures the best approach for both safety and effectiveness. Following Beike protocol, doctors at the treatment center prescribe a specific combination best suited to treat the underlying disorder after the initial check-up on arrival. The injections are minimally invasive and yet highly effective in delivering stem cells to the damaged parts of the body. In-depth information about each type of injection can be found below. INTRAVENOUS (IV) INJECTION The Intravenous (IV) delivery method is a very simple process and familiar to most patients. A tubing line with a catheter tip threaded over a needle is placed into the patient’s vein. Once proper placement is obtained, the needle portion is removed and the flexible plastic catheter is left in place in the vein with the tubing attached. The stem cell suspension will be administered through the IV after Dexamethasone, which may be administered to avoid any potential allergic reactions. Typically, no sedation is required for this procedure. The entire IV injection process takes less than 45 minutes to complete. The most common risks involved in this procedure include the formation of a small hematoma or blood clot under the injection site. Since sterile procedures are followed during the entire process, the risk of infection is minimal. INTRATHECAL (IT) INJECTION An intrathecal injection (IT) is also commonly referred to as a spinal tap. It is a procedure used to access the cerebrospinal fluid (CSF) of the brain and spinal cord, and helps to deliver stem cells directly into the CSF, by-passing the blood-brain barrier. Our doctors have determined that this is the least invasive method for delivering stem cells directly into the central nervous system. CSF is used by the body to provide protection for the brain and spinal cord, limiting the possibility of injury to these vital areas. CT-GUIDED INTRASPINAL CORD INJECTION For patients with spinal cord injuries (SCI), especially diagnosed with complete SCI or incomplete SCI with severe disorder, the CT-guided intra-spinal cord injection of stem cells (if deemed necessary by the doctor based on medical condition) will be performed after the spine-MRI has been conducted to identify the exact injury sites. INTRAMUSCULAR INJECTION Our doctors have found that intramuscular injections of stem cells can assist patients with muscular dystrophy to receive better health gains. These injections are made directly into the muscles of the affected area(s). The delivery method has also been applied to treat lower limb ischemia and diabetic foot patients. INTRAVASCULAR INTERVENTIONAL INJECTION Intravascular interventional injection can be applied to place stem cells directly into target organs or tissues using image guidance while the patient is under local anaesthesia. The procedure can be applied for myocardial infarction, cardiomyopathy, liver cirrhosis and chronic renal failure, among others. INTRA-ARTICULAR INJECTION Patients with arthritis can be considered to receive stem cells through intra-articular injection. This procedure can be performed as a simple injection using a syringe directly into the cavity of the affected joints. RETROBULBAR INJECTION This injection is given into the soft tissue present behind the eyeball for certain diseases like optic nerve hypoplasia, optic atrophy, etc.
Adverse Reactions We understand that patients may have concerns about adverse reactions to the stem cell transplants. Side effects experienced by our patients are consistent with expected reactions for routine IV and LP injections. The most common reactions to the treatment are fever, headache, leg pain, diarrhoea, vomiting, and allergic reactions. Less than four percent of patients experience any of these symptoms.

Rehabilitation At Unistem, the treatment program includes daily rehabilitation excluding the days on which the injection is administered and the following day. Most patients undergo two sessions a day. This program consists of a tailored mix of physiotherapy, acupuncture and massage. Our therapist will decide what combination is appropriate for each individual. An on-site evaluation is done upon arrival. We firmly believe that physical stimulation aids the stem cells in their work. For ailments like spinal cord injuries, cerebral palsy and brain injuries, it is important that the patient continues his or her exercises as much as possible following treatment. If the patient already has a customised physical therapy regimen or a highly specialised therapy program they might like to continue, they are requested to bring the video documentation to share with our therapists. Our therapists can assist with this therapy or they may recommend an alternative regimen should the patients choose to continue.
Therapy Disclaimer Stem cell therapy using tissue stem cells does not fall under the realm of accepted modalities of treatment. The results reaped from this therapy may differ from person to person.

In accordance with the ICMR guidelines, Unistem has constituted an Institutional Committee for Stem Cell Research (IC-SCR), to evaluate, approve and monitor all stem cell related activities.

A Data Safety and Monitoring Board (DSMB) has been setup to independently evaluate and monitor treatment outcome for safety and efficacy.

At Unistem, we are focused on giving patients functional improvement in their quality of life. The treatment is individualised to the specific requirements of each patient.

The ethical guidelines followed by Unistem and partnering hospitals are based on and are in accordance with the World Medical Association’s WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects — “In the treatment of a patient, where proven interventions do not exist or have been ineffective, the physician, may use an unproven intervention if in the physician’s judgment it offers hope of saving life, re-establishing health or alleviating suffering.”
(para 35; http://www.wma.net/en/30publications/10policies/b3/index.html).

Unistem is presently utilising tissue stem cells derived from the umbilical cord for the cell transplantation therapy due to their preliminary safety and efficacy. These are also referred to as “adult stem cells”, “mesenchymal stem cells”, etc. The usage of these cells has been put in the permissive category in the guidelines issued by ICMR.

Prior to the therapy, a special informed consent is taken which covers aspects of voluntary enrolment.