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India is home to close to 97,000 children with type 1 diabetes

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New therapy on the block: Cell based therapy shows promise in treatment of diabetes

One may say that diabetes is rapidly becoming a global epidemic which spares neither adults nor young children and adolescents. The cause for concern is the need for lifetime medications and/or insulin to manage symptoms and prevent complications. Also, the emotional and financial burden posed by various forms of diabetes (Type 1, Type 2, Gestational Diabetes and Latent Autoimmune Diabetes in Adults) raises the need for development of newer definitive therapeutic modalities.

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Today, being Children’s day and World Diabetes Day, we share information on one of the forms of diabetes that affects young individuals and by far is the most challenging to manage considering the early age of onset of the condition.

Type 1diabetes is becoming one of the most common illnesses in younger individuals. India is home to close to 97,000 children with type 1 diabetes. Although this type constitutes only 5-10% of the total population, it has serious short and long term consequences. The condition results due to pancreatic beta cell destruction which causes absolute insulin deficiency. Genetic and environmental factors as well as disorder of immune mechanism are thought to be the cause of type 1 diabetes. Treatment involves use of insulin/oral medicines, dose of which is adjusted based on regular blood glucose monitoring. Also, continuous monitoring of the general condition of the patient is of paramount importance so as to assess development of complications. Diabetes is associated with microvascular (retinopathy, nephropathy, and neuropathy) and macrovascular (cardiovascular, cerebrovascular, and peripheral vascular disease) complications.

Dr. Pradeep Mahajan says “You carry your own repairing kits in your body”. He believes in the power of cellular therapy to address the root cause of many conditions rather than palliative management of symptoms. The rationale behind use of cellular therapy for diabetes is that, stem cells have tremendous regenerative capacity and the flexibility to grow into different types of cells. Progenitor cells in the human body are capable of differentiating in vivo to produce beta cells—the islet cells that manufacture insulin—as well as pancreatic islet cells. Cell-based approach to insulin replacement has been shown to ultimately improve glucose control in patients with type 1 diabetes. Furthermore, mesenchymal stem cells have immunomodulatory property that aids in restoring immune homeostasis/balance in the body.

Patients and their families are generally unaware of this recent form of therapy for diabetes. It is therefore mandatory, that the patient is explained about his/her disease condition and what benefits may be achieved through cellular therapy. At StemRx, during the patients’ first visit, a detailed case history is taken. When the patient consents for treatment, he/she is directed to undergo hematological and radiological investigations specific to his/her health condition. This is followed by a second round of consultation during which reports of investigations and treatment protocol for the patient are discussed in detail.

Cellular therapy protocol at StemRx involves harvesting cells from the patients’ own body (autologous stem cells) from bone marrow, fat tissue and peripheral blood. These sources are rich in mesenchymal stem cells and have the advantage of availability of cells and ease of harvest. After activation the cells are transplanted into the appropriate site in the patients’ body. Hospitalization is advised for 48 hours after the procedure to monitor the general condition of the patient and to allow for homing of cells. Since the source of cells is from the patients’ own body, treatment is safe and is not associated with any adverse events.

Lifestyle and diet are two other factors that play a major role in prognosis of diabetes. Food is a major concern for parents as children in particular tend to have specific tastes and can be quite demanding. This poses even greater difficulty when the child is diabetic. Meal planning can get tricky, but should be consistent, flexible, and supply the necessary nutrients. The aim of diet planning is to satisfy the child’s appetite along with balancing sugar and promoting normal growth and development.  The patient discusses the diet followed by them with our in-house dietician. Based on the requirements, modifications may be advised to achieve a balanced diet, specific for the patient. A diet that is high in fiber, low in saturated fat and sugar is generally advised to diabetic patients.

Another important factor, physical activity has been shown to improve lipoprotein profile, cardiovascular health and reduce blood pressure. Prevention of long-term complications arising due to diabetes may be possible through physical exercise. However, it should be ensured that hypoglycemia be avoided, which occurs immediately or after prolonged intensive workout. Children in particular are more prone to variability in blood glucose levels. Therefore, we advise moderate intensity leisure activities, recreational sports as well as physiotherapy exercises depending on the overall status of the patient. The goal is to teach patients to incorporate exercise in their daily lives, in addition to diet management as a means to improve/maintain insulin sensitivity post treatment.

Results of cellular therapy are generally observed after 1-2 sessions of cellular therapy. Reduction in blood glucose levels are noticed along with improvement in general health of patients. However, changes in the patients’ ongoing insulin doses/oral hypoglycemic drugs are made only after a steady state of blood glucose is achieved. Accordingly, dosage is adjusted and ultimately discontinuation of medications/insulin may be advised.

Cellular therapy addresses the root cause of diabetes, ie: beta-cell destruction and insulin resistance.  Therefore, results achieved, although gradual are permanent. The number of sessions of cellular therapy required differs with each individual, based on age, diabetic status and presence of co-morbid conditions as well as lifestyle. Additionally, patient compliance with respect to following diet and allied therapies is equally important to achieve optimum benefit from therapy.

Case report

17 year old Tania had a history of road traffic accident at the age of 12 years. When she was hospitalized, it was detected that she had high blood glucose level. However, the high level was considered as post trauma effect. She also had a history of repeated fainting episodes while at school, but this was usually attributed to weakness. At 14 years of age, Tania had complained of body and abdominal pain, weakness and she fainted on her way to hospital. This time, she was diagnosed with Type 1 diabetes mellitus based on her symptoms and blood investigation which revealed high blood glucose level (random blood sugar and HbA1C).

Our patient, Tania was prescribed 2 forms of insulin. She achieved some control, though there was constant fluctuation in blood sugar level. Moreover, Tania continued to complain of general weakness, occasional abdominal pain, tingling sensation in toes and facial pigmentation.

Tania was advised 2 sessions of cellular therapy with diet modifications and physiotherapy. Response to treatment was noticed immediately after 1st session of therapy. A gradual reduction in blood glucose level was noticed, but the main improvement within 10 days of treatment was reduced lethargy. During her 1st month follow up, insulin dose was reduced from 20 units to 16 units a day. Three months following treatment, Tania was advised to completely stop one form of insulin and dose reduction of the second form to 6 units (from previous 16 units) was advised. A year after cellular therapy, Tania has now completely discontinued both forms of insulin. Improvement in skin pigmentation and overall energy levels is also noticed.

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