Current Status of Stem Cell Therapy in India

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Stem cell therapy is an integral part of regenerative medicine and is known to show promising results when incorporated practically. Its purpose is to generate healthy cells to replace the ones that get damaged due to the disease. Stem Cells are unique human cells that are self-sustainable, undifferentiated, and hold the potential to replicate into other cell types, ranging from muscle cells to brain cells. They are divided into- Embryonic Stem Cells and Adult Stem Cells. Embryonic Stem Cells are pluripotent meaning- they have the ability to turn into more than one type of cell. Whereas, Adult Stem Cells are derived from fully developed tissues such as liver, skin, brain, bone marrow and can only turn into the respective tissue it has been derived from. Another variant, also known as Induced Pluripotent Stem Cells are derivatives of Adult Stem Cells but are then processed in laboratories to function like Embryonic Stem Cells.

According to the United Nations, around 80 diseases and ailments can be cured using stem cells derived from the Umbilical Cord. But, in theory, there has been no boundary set for the number of diseases and ailments that can be cured using stem cell therapy.

Stem Cell Therapy is used:

  • In treating malignant blood related disorders of immune system – leukemia, multiple myeloma, lymphoma.
  • In Organ Transplant to replace critically damaged tissue or organ. In Liver Cirrhosis using Hematopoietic stem cells. In Kidney disease using mesenchymal stem cells to control the inflammatory progression.
  • In degenerative diseases which cannot be treated with conventional treatment modalities. In Alzheimer’s disease, to help with the progression of the disease by neurogenesis. In Multiple Sclerosis which is an autoimmune disorder, using Hemopoietic derived stem cells. In Duchenne Muscular Dystrophy, stem cells act by spreading muscular proteins and facilitating rejuvenation. In Motor Neuron Disease; Especially Amyotrophic Lateral Sclerosis. In Neurological disorders – Parkinsonism, Autism, Stroke, Spinal cord injury. In Ataxia for slowing the disease progression by providing nutrition to the ceasing cells and rejuvenation. In Traumatic Brain injury including concussion, contusion, diffuse axonal injury, penetration injury. In Cerebral Palsy for prevention of further neuronal degeneration by myelin sheath regeneration thus halting further brain damage. Stem cells used here are derivatives of Mesenchymal stem cells, Umbilical Cord stem cells, Induced Pluripotent stem cells and Natural stem cells. In Intellectual Disabilities using autologous stem cells derived from bone marrow to repair areas of brain damage facilitating rehabilitation.
  • In Mononeuropathies such as Ulnar nerve palsy, Radial nerve palsy, Peroneal nerve palsy and Polyneuropathies – stem cells that are derived from the adipose tissue or bone marrow are injected at the site of damage leading to nerve regeneration bringing back the normal function.
  • In Anti-Aging, Dryness and Itching, Age Spots, Shingles for skin rejuvenation, mesenchymal stem cells are injected into the skin layer which reverse the skin damage due to sun exposure over the years. In Hair loss- Alopecia Areata using mesenchymal stem cells derived from umbilical cord. In Burns patients with severe burns covering maximum Body Surface Area (BSA) for growing skin grafts, although they have been known to lack sweat glands and hair follicles. In Major Abrasions using Adipocyte derived stem cells and Bone marrow stem cells for re-epithelialization and tissue building. In Critical Limb Ischemia for repair and early rehabilitation using Induced Pluripotent stem cells.
  • In Cardiac issues and Cardiovascular diseases such as Coronary Artery Disease, Peripheral Artery Disease, Pericardial disease, Aortic disease, Heart Valve Disorders, Cerebrovascular disorders, Deep Vein Thrombosis for regeneration of damaged heart cells in order to improve the cardiac performance. These stem cells release paracrine factors which are known to be cardioprotective and boost regeneration.
  • In Chronic conditions like Rheumatoid Arthritis, Hamstrings Tendinopathy, meniscal tear, sprain, Shakiness of knee, Cartilage impairment for regeneration of cartilage tissue using Mesenchymal stem cells. In Arthritis and Osteoarthritis for tissue healing and repair using mesenchymal cells derived from human umbilical cord tissue that are known to have anti-inflammatory and immunosuppressant properties.
  • In Chronic Obstructive Pulmonary Diseases (COPD) like Bronchial Asthma, Bronchitis, Emphysema, Bronchiectasis and Interstitial Lung disease using Mesenchymal stem cells.
  • In Diabetes Type 2. It is also used to produce insulin for Type 1 Diabetes aka Juvenile Diabetes. In Diabetic Nephropathy using Mesenchymal stem cells for the repair of interstitial tissue-epithelial cell injury. This slows down kidney deterioration while boosting the immune system to prevent further damage. In (Diabetic) Erectile Dysfunction although the effects are known to be manifested slowly and are not proven completely yet.
  • In Eye injuries, Optic Nerve Atrophy, Optic Nerve Hypoplasia, Retinopathy, Retinal Detachment, Retinitis pigmentosa, Macular degeneration using stem cells, there is potential to rectify vision which has been proved in the clinical trials. In Age-related Macular Degeneration (dry type) as the impairment lies in Retinal Pigment Epithelium (RPE), stem cells can be used to generate the RPE and transplant it. In Glaucoma: Open-angle glaucoma, Closed-angle glaucoma, Normal-tension glaucoma, Congenital glaucoma.
  • In Females to treat Infertility using mesenchymal stem cells derived from the patient’s adipose tissue or fetal stem cells.

Like Ronald Reagan said, “Stem cell research can revolutionize medicine, more than anything since Antibiotics”, the prospective use of stem cells holds the capability to expand and the researchers in India are gaining significant results in doing so while abiding to the ethical guidelines framed by ICMR (Indian Council of Medical Research), NAC (National Apex Committee) and the Institutional committee (for research at institutional level) especially since India has become the global centre to conduct stem cell research trials. A few prohibitions and restrictions to stem cell research that pertain due to ethical concerns include reproductive cloning, human embryo implantation in the uterus after maneuvering it in vitro, SCNT (Somatic Nuclear Cell Transfer) generated human blastocyst transfer into human or non-human uterus and chimera study, zygote creation using techniques like in vitro fertilization and SCNT that aim to specifically derive human Embryonic Stem (hES) cell line.

The current status of stem cell therapy in India is facing enormous criticism from the media, public and the government in play. In conducting research, unused embryos are used to derive Embryonic stem cells via. in-vitro fertilization. But in the treatment of disease, bone marrow derived adult stem cells aka. Hematopoietic stem cells are used especially in bone marrow transplant procedures. The new ICMR-DBT guidelines and CDSCO (Central Drugs Standard Control Organization) draft have been framed around compensating the participants in clinical research who have suffered an injury. This solves one of the several questions that challenge us today while being in accordance with the International Scientific Community. The recent developments show the up-rise in molecular biology tools and techniques in stem cell research and its application to human diseases. Irreversible, incurable, degenerative diseases- Alzheimer’s, Cancer, Diabetes, Parkinson’s, Traumatic brain injuries have shown substantial, progressive results after stem cell therapy implementation. Also, in recent times, Adult Pluripotent stem cells with abnormal DNA have been identified. Because these cells are present in trace amounts in human bodies and are difficult to culture in a laboratory setting, researchers are finding a solution to overcome this. Research on making undifferentiated micro-organism derived pluripotent stem cells is being incorporated for patients with limbal cell dysfunction and also on retinal epithelial cells made from pluripotent stem cells’ aid in the loss of vision especially in condition like age-related macular degeneration is in process. According to the researchers, the current goal is to enable stem cells to generate healthy cardiac tissue in a laboratory and then transplant this healthy cardiac muscle tissue in patients with a diseased heart therefore aiming to cure chronic heart conditions. New research exploring the interaction of medications with cells formed after pluripotent cell transplant is also being conducted. In cases of wound healing, there’s evidence of stem cell secretome enhancing the process but problems regarding isolation approach heterogenicity, phenotype characterization and sourcing of stem cells have surfaced which are inhibiting the real-life implementation of the research. So far there’s only proof of active wound healing in experimentation on small laboratory animals while it’s a huge challenge in bigger laboratory animals. Developing a new research strategy regarding the same would need abundant availability, compatibility and proper vascularization.

A shortcoming faced by the researchers is the evidence of embryonic stem cells being rejected by the body. Hence, they are now focused on understanding the mechanism of embryonic stem cell growth and functioning to gain a better control over the cells after transplantation. On the other hand, Embryonic stem cells are being utilized to study illnesses, drug interaction, drug screening for their fatal adverse effects.

The ethical and policy issues lie at the base of understanding Stem cell research. To quote Tom Harkin- “Stem cell research holds enormous promise for easing human suffering, and federal support is critical to its success.” It has a consequential ethical aspect which should always be of primary consideration and should comprise prior informed consent, voluntary decision-making, community agreement, nonexploitation of privacy and confidentiality, transparency, precautions and risk minimization, accountability and professional competency. These components are required to take into consideration maximization of public interest and judicial distribution.

The author of this article feels strongly towards spreading awareness and educating the public regarding stem cell research. The embryos that are left from ivF procedures are used in conducting research after consent from the progenitors to discard them. But due to the cultural stigma revolving around infertility and ivF technique, the patients keep silent about undergoing treatment and do not consent for the discarded embryos to be used in research as it is considered taboo. This is precisely why imparting results of research in Layman terms to the audience and encouraging them to participate in public discussions is important if new techniques regarding stem cell therapy need to be applied for social impact.


 

 

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About the author

Dr. Mitali Choudhary is a 2023 MBBS graduate who plans on changing the world one day at a time through her passion towards medical research. Her interests include reading, exploring new places, cooking, music and she takes pride in having a song for every situation.

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