'cures' and 'treatments': Caution Advised

Stem Cell Therapy

::: {.callout-caution} As of 2022, the use of stem cell therapy as a treatment or cure for autism is prohibited in India. This restriction has been implemented due to misleading promotions and false claims. The only way to legally and ethically access stem cell therapy is to participate in an approved clinical trial. :::

What are stem cells?

Stem cells are a group of cells that are present in our bodies through all stages of life. In fact, they are one of the first cells developed during the embryo stage. These cells, under the right environment, have the ability to generate new stem cells and also other cells with specialized functions (blood cells, brain cells, bone cells etc.) Because of this unique feature, stem cells play a key role in the development of newborn children and also in the restorative processes after a disease or an injury. Their ability to self-renew and multiply, ensures an ongoing source of new cells to replace old or injured ones. During the developmental years, this growth is vital for maturing into an adult. Once development is complete, this ongoing growth aids in healing and repairing damaged tissues or organs at a cellular level. These special characteristics make stem cells highly important in regenerative medicine, as they can create entire tissues and organs from just a small group of precursor cells.This characteristic of stem cells has kindled research interest in trying this as a treatment for various diseases.

What is stem cell therapy?

Stem cell therapy, also known as regenerative medicine, aids in fixing damaged, malfunctioning, or injured tissues using stem cells or their byproducts. It marks a new phase in organ transplantation, utilizing cells rather than donor organs that are limited.

In laboratories, scientists cultivate stem cells under favorable conditions. These cells are modified to become specific cell types, like heart muscle, blood, or nerve cells. These specialized cells can be placed into a person's body. For instance, if someone has a heart condition, these cells might be inserted into the heart muscle. The transplanted healthy heart muscle cells may assist in repairing the damaged heart muscle.

History of stem cell therapy

Zoologists Theodor Heinrich Boveri and Valentin Häcker used the term stem cell to describe cells committed to give rise to the germline.

  • 1950s - scientists studied the potential of stem cells majorly through bone marrow and its role in generating various blood cells

  • 1956 - first successful bone marrow transplant was done. This procedure laid the foundation for using stem cells in medical treatments, especially in treating diseases like leukemia and other blood-related disorders.

  • 1981 - mouse embryonic stem cells was first cultured in the laboratory

  • 1988 - first umbilical cord blood stem cell transplant took place in a child with Fancoi’s anemia.

  • 1998 - scientists isolated and cultured human embryonic stem cells. This breakthrough enabled researchers to work with cells that had the potential to develop into almost any cell type in the human body. This discovery opened up new possibilities for regenerative medicine and treatment of a wide array of diseases and injuries.

  • 2006 - Discovered the technique of human-induced pluripotent stem cells (iPS), which involves transforming adult skin cells into cells that closely mimic human embryonic stem cells

  • Presently, stem cell therapy is applied in various areas of medicine. For example, bone marrow transplants are used in the treatment of leukemia and other blood disorders. Stem cells are being researched and utilized for regenerative medicine to potentially treat conditions such as heart disease, spinal cord injuries, Parkinson's disease, diabetes, and more. Clinical trials and research studies continue to explore the safety and efficacy of stem cell therapies for various health conditions.

Why was it tried for autism?

Stem cell therapy has been considered as a potential treatment for autism due to the belief that it might target certain biological mechanisms or symptoms (immune system regulation and inflammation, neural connectivity, etc.) associated with the condition.

Reasons why stem cell therapy is being explored for autism include:

  • Regenerative Potential: Stem cells possess the capability to transform into various cell types. The idea is that they might aid in repairing or regenerating damaged or dysfunctional cells in the brain or nervous system, potentially impacting autism-related symptoms.

  • Inflammation and Immune Modulation: Studies suggest that immune system dysregulation or inflammation might contribute to certain cases of autism. Some types of stem cells, particularly mesenchymal stem cells, have shown potential in regulating immune responses and reducing inflammation. Researchers hope that this immune-modulating ability might alleviate certain autism-related symptoms.

  • Neuroprotective and Neurotrophic Effects: Stem cells produce substances that support the growth and survival of neurons. Researchers explore whether stem cells could protect existing neurons, encourage neuronal growth, and potentially enhance neural connections in individuals with autism.

  • Experimental Nature of Treatment: While conventional treatments for autism primarily focus on behavioral and therapeutic interventions, stem cell therapy is considered experimental. It aims to address potential underlying biological factors that traditional therapies might not directly target.

However, it's essential to understand that while stem cell therapy has shown promise in various medical areas, its effectiveness and safety in treating autism are still being investigated. Clinical trials exploring the safety and potential efficacy of stem cell therapy for autism began in the early 2010s. These trials aimed to investigate the safety, feasibility, and any potential improvements in behavior, communication, and other symptoms associated with autism. It remains an experimental and unproven treatment for autism.

The scientific and medical community stress the necessity for further comprehensive research, including well-designed clinical trials, to determine its safety, efficacy, and long-term impact on individuals with autism.

Caution

Stem cell therapy for Autism is still under investigation and there is no established finding of cure in using the treatment for autism. There are limited studies and no definitive results yet. Among the limited studies, the results cannot be generalized as all of the studies have a small sample size. Like any medical intervention, stem cell therapy also carries potential risks.

  • Unintended side effects or complications could arise from the procedure, such as infection, immune rejection, or the formation of tumors.

  • The outcomes of stem cell therapy for autism can vary widely from person to person. It's difficult to predict how an individual will respond to the treatment or if it will have any positive effects on their symptoms.

  • It involves invasive medical procedures and requires the individual to be admitted for at least 5 days. Furthermore, the treatment is hard on the pocket when done commercially.

  • Some facilities offering stem cell treatments might not adhere to strict regulatory standards or might lack sufficient scientific evidence supporting their procedures. If any medical center is experimenting and an individual is part of a clinical trial, they should be treated free of cost.

  • There have been reports of adverse short-term effects associated with stem cell therapy, including aggressive behavior, nausea, vomiting, and seizures. Research on the long-term effects of stem cell therapy is still in its early stages, and a comprehensive understanding of its lasting impact is yet to be established.

Current status in India

Starting around 2010, stem cell therapy has been advertised as a potential cure for autism by many practitioners in India, despite no evidence for the same. Many parents have fallen victim to the unethical medical and business practice associated with stem cell treatment.

As of 2022, the use of stem cell therapy as a treatment or cure for autism is prohibited in India. This restriction has been implemented due to misleading promotions and false claims. Currently, stem cell therapy for conditions outlined in the National Guideline for Stem Cell Research (NGSCR) 2017, excluding Bone Marrow Transplant (BMT)/ hematopoietic stem cell transplant (HSCT), is neither accessible nor permitted. Individuals can only participate in stem cell treatment through a clinical trial if they meet the specified criteria for the trial.

In this context, it's important to highlight that there is currently no clinical evidence validating the effectiveness of stem cell therapy for treating autism. Therefore, any facility claiming otherwise should be approached with caution and careful consideration. The National Medical Council (NMC) calls it professional misconduct when anybody practices, advertises, or promotes stem cell therapy as a treatment or cure for autism.

Given these factors, families considering stem cell therapy believing it will lead to significant improvements or a cure for autism need to seriously reconsider and make an informed decision. The only ethical and scientific way to get stem cell therapy is to participate in a well designed clinical trial or study. The path ahead demands a cautious approach to verify the safety, efficacy and long term impacts of the therapy.

Here is a video created in 2023 by Yash Charitable Trust (YCT), and Forum for Autism, against the use of stem cell therapy as a treatment.

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