Stem Cell Therapy in India 2020

Stem Cell Therapy in India 2020: A Complete Guide

Stem cell therapy in India is showing promising results for several diseases and disorders.The treatment helps in repairing injured or dysfunctional tissues or organs using stem cells.

Stem Cell Therapy in India and Stem Cell Banking in India has been quite the buzzword in the Indian healthcare community for quite a long time.

Stem cell technology and research has emerged as a prominent field of biomedical sciences

with applications in several fields like developmental biology, tissue engineering, drug development, disease modeling, etc.

Stem Cell research has been popular worldwide for being the “Panacea of all ills” (Cure of all illnesses)

though this expectation has not been met yet.

So let’s take a dig at one of the most grossing fields of biomedical sciences

Stem Cell Therapy, Research & Banking

If a topic catches your eye feel free to skip 

What are Stem Cells?

Embryonic Stem Cells
Embryonic Stem Cells

Our bodies contain several organs such as the brain, bones, heart and reproductive organs, The basic undifferentiated cells that give rise to all of these organs are called the stem cell.

Stem cell usage include 

  • Stem cells can repair damaged organs by replacing them with new cells grown in the lab

  • Correct organ functioning in case an organ does not work properly 

  • Help in research of genetic diseases

  • and, testing the effectiveness of new drugs 

Where are stem cells found in our body?

Let’s look at all the different type of stem cells in humans 

  1. The Zygote: Zygote is an egg cell from a woman that has been fertilized by a sperm from a man

    This single cell is the first cell in a developing human being; it’s also called a totipotent stem cell

    because it can form any type of cell in the body as well as the umbilical cord and placenta.

  2. Blastocyst Embryonic Stem Cell: When the single-celled zygote has divided a few times it becomes an early-stage embryo called a blastocyst, Which is rich in stem cells.

    the blastocyst embryonic stem cells are pluripotent this means they can form any cell in the body

    but not the cells in the umbilical cord or placenta

  3. Adult Stem Cell: these cells are found in some organs such as the skin, bone marrow, liver, heart and blood vessels after birth and into adulthood

    Adult Stem cells are multipotent this means that they can only become a few different cell types related to the organ

    for example, the skin contains a small number of adult stem cells that can divide to create new skin adult stem cells

    or they can become more specialized skin cells to replace those that are lost due to cell aging or damage

In the lab, scientists can now induce or cause a regular body cell such as a skin cell to change into a pluripotent stem cell-like embryonic stem cells.

These induced pluripotent stem cells can become any type of cell in the body

To sum up

What is stem cell therapy?

Stem cell therapy or Stem cell transplant is also referred to as regenerative medicine,

The treatment helps in repairing injured or dysfunctional tissues or organs using stem cells. 

Stem cell therapy is evolving as an alternative to organ transplantation.

Getting donor organs is really difficult for many patients as they are limited in number, This therapy uses stem cells in place of donor organs.

For example,

If a patient is suffering from a kidney disease, Stem cells can be injected into the kidney.

These healthy kidney cells with help in repairing the injured kidney cells.

In India, stem cells and their derivatives fall under the definition of ‘Drug’ as per the Drugs and Cosmetics Act 1940,

and are categorized as ‘Investigational New Drug (IND)’ or ‘Investigational New Entity (INE)’ when used for clinical application

For which diseases is stem cell therapy available in India?

Stem cell therapy is showing promising results for several diseases and disorders around the world,

Stem cell therapy in India is used to treat several hematological, immunological and metabolic disorders like

  1. Diseases and Cancers of the Blood (Hematopoietic Disorders) like 

    1. leukemia, 
    2. Aplastic Anemia, 
    3. Thalassemia,
    4. Myelodysplastic syndrome
    5. Sickle Cell Anemia, 
    6. Blood Storage Disorders.

  2. More than 80 Neuromuscular and Degenerative Disorders like

    1. Autism
    2. Spinal Cord Injuries
    3. Muscular Dystrophy
    4. Dementia
    5. Cerebral Palsy
    6. Head Injuries
    7. Motor Neuron Disorders
    8. Intellectual Disabilities 
    9. Stroke.

According to the Indian Council of Medical Research & Department of Biotechnology,

following are the list of diseases that are allowed to be treated using stem cell therapy

Stem cell therapy and research in India and around the world is still an evolving science.

Stem Cell Therapy can not be used to treat any other disease or disorder apart from the once listed in India

unless new research proves more application

Stem cell therapy in India process

Stem cell therapy involves 3 key steps 

  1. Blood Extraction 

  2. Separation of Stem Cells 

  3. Stem Cell Injection

Step 1: Blood Extraction

Stem cells mostly used in therapy are either derived from the umbilical cord of the person if preserved or by donor stem cells

or adult stem cells derived from the bone marrow of the patient which is rich in adult stem cells

If stem cells are to be extracted from the bone marrow it is also of the patient the easiest route is through the hip bone 

Under local anesthesia, a bone marrow aspiration needle is inserted in the hip areas and blood is drawn 

Step 2: Separation of Stem Cells

Extracted blood is processed in the lab, Due to the difference in the density a centrifuge machine separates stem cells from normal blood cells,

This process takes about 5-6 hours 

Step 3: Injecting Stem Cells

The stem cells are injected into the damaged tissue or organ directly using a clinical needle.

For example, in cases of muscular dystrophy, the stem cells are inserted in the damaged muscles 

Stem cell therapy in India cost

Stem cell therapy is a promising science but is also really expensive.

The cost of stem cell therapy in India starts from 5000 USD (3.78 Lakh Rs) and may go up to 10,000 USD (8 Lakh Rs).

The cost of stem cell therapy depends on the type of stem cell used 

Adult Stem Cell Therapy Cost in India3.78 Lakh Rs ( 5000 USD)
Placenta Stem Cell Therapy Cost in India4.54 Lakh Rs (6000 USD)
Embryonic Stem Cell Therapy Cost in India4.8-5 Lakh Rs (6500 USD)
Fetal Stem Cell Therapy Cost in India5.2-5.5 Lakh Rs (7000-7200 USD)
Induced Pluripotent Stem Cell Therapy Cost in India5.5-5.7 Lakh Rs(7200-7500 USD)

You might think that the cost of stem cell therapy in India is really high but,

it may amaze you that the cost of stem cell therapy in India is quite cheap compare to other countries.

CountryAverage Cost
Cost of Stem cell therapy in the United States (USA)$13,200
Cost of Stem cell therapy in the United Kingdom(Uk)$10,520
Cost of Stem cell therapy in Thailand $7,920
Cost of Stem cell therapy in Singapore$9,400
Cost of Stem cell therapy in China$18,000
Cost of Stem cell therapy in Saudi Arabia$6,000
Cost of Stem cell therapy in South Africa$6500
Cost of Stem cell therapy in UAE$6000

The cost of stem cell therapy is quite high and not all of us can afford it.

More research and development is needed to make this therapy affordable and available for masses

and only then can this developing science be called a breakthrough treatment. 

to sum up the above discussion

Guidelines for stem cell research and therapy in India 

The Indian Council of Medical Research and Department of Biotechnology in 2017 released guidelines for stem cell research and practices.

You can check out the detailed guidelines in the link given below

National Guidelines for Stem Cell Research and Practice

The Key Highlights are:

  • Prior to the procurement of biological material for the isolation of stem cells,

    it is mandatory to obtain informed consent from the voluntary donor

  • Prohibited Areas of Research 

    • Research related to human germline gene therapy and reproductive cloning. 

    • In vitro culture of intact human embryos,

      regardless of the method of their derivation, beyond 14 days of fertilization or formation of the primitive streak.

    • Clinical trials involving xenogeneic cells. 

    • Any clinical research on Xenogeneic-Human hybrids. 

    • Use of genome modified human embryos, germ-line stem cells, or gametes for developmental propagation.

    • Research involving the implantation of human embryos (generated by any means) after in vitro manipulation,

      at any stage of development, into the uterus in humans or primates. 

    • Breeding of animals in which any type of human stem cells have been introduced at any stage of development,

      and are likely to contribute to chimeric gonadal cells.

  •  It is mandatory that the stem cells or their products/derivatives are processed in CDSCO licensed facility

  • Quality control and assurance for product development including cell processing and manufacturing stages is critical

    and should be compliant with requirements as per Schedule M of Drugs and Cosmetics Act, 1940 and rules therein

  • The infrastructure facility shall be duly certified by CDSCO, and submit the CMC documents for necessary regulatory approvals.

  • At present, there is a lack of solid scientific evidence to substantiate the clinical efficacy of stem cells in a disease state

    other than their use for hematopoietic stem cell transplantation (HSCT) and treatments mentioned above

  • Minimal Manipulation: This refers to the situation where the processing neither alters the number nor the biological characteristics

    and function of the cells (or tissue) relating to their utility for reconstruction, repair, or replacement.
  • In vitro studies using stem cells isolated from tissues can be done with prior approval of IC-SCR and IEC.

    Creation of human pre-implantation embryos by IVF, ICSI, SCNT, or any other method with the aim of deriving ESC lines for any purpose.

    The investigator needs to provide reasoning
    • The proposed research cannot be carried out with existing ESC lines, or those that can be derived from spare embryos.  
    • Minimum number of embryos/blastocysts required for such research must be clearly defined. 
    • Research teams should have appropriate expertise and requisite training in derivation, characterization, and culture of ESCs. 

What is Stem Cell Banking?

Stem Cell Banking in India
Stem Cell Bank

Stem cell banking is the process of stem cell preservation for possible future use.

These stem cells can help you repair damaged organs by replacing them with the preserved stem cells 

Ond of the most popular stem cell banking in India is “The Cord Blood Banking”, It is the extraction of stem cells of baby from the umbilical cord.

These stem cells are pluripotent and are rich in quality they can for almost all types of cells in your body.

Stem cell extraction in this phase is painless and hassle-free

The cost of stem cell banking in India starts from 15,000 Rs one-time cost with a yearly maintenance charge of 3000-4000 Rs.

Many labs offer a variety of deals for stem cell banking which involve lifetime maintenance or for long periods of time like 21-30 Years

Some other popular stem cell banking sources are

Placenta, Amniotic Sac and Amniotic Fluid these are richest sources of stem cell in terms of quality and quantity 

Controversy involved with stem cell research and therapy

Here are some key highlight around the stem cell research and therapy highlights

  1. Use of embryos for creating human embryonic stem cell may lead to commoditization/commercialization of human cells and tissues

  2.  The potential danger of tumorigenicity (leading to tumors or cancer) of stem cells,

    considering their capacity for unlimited proliferation (Multiplication)

  3. possible risk of contamination and genomic changes arising due to in  manipulations of the cell outside the body

  4. limitations related to immunological tissue incompatibility between individuals

One of the hot topics in this debate is that at what point do we consider life to begin?

And is it ethical to destroy embryo cells (Which are living cells that develop into a complete human) to cure patients?

But, A thing to consider is that every day many embryo cells are formed in IVF clinics across the world

and not all of them are used for achieving pregnancy.

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