STEM CELL BANKING

 

STEM CELL BANKING

Stem cell banks are increasingly seen as an essential resource for biological materials for both basic and translational research and medical treatment. Stem cell banks support transnational access to quality-controlled and ethically sourced stem cell lines from different origins. Though certain ethical and legal concerns exist with some types of stem cells, stem cell banking could do well to examine the approaches fostered by tissue banking. Like bio-banks, stem cell banks have the core objective to ensure the availability of quality and ethically approved cells or embryos for research and eventual therapies.

What is Stem Cell Banking?

A stem cell bank is a facility that stores normal stem cells without any genetic alteration or exposure to chemicals and drugs for the purpose of future use in products or medical needs. The cells are tested before, during, and upon completion of the cell banking process, or before being used for treatment. 

It is the most straightforward way of providing natural pluripotent stem cells either to the same individual, if it was stored for personal use, or as a pooled source for allogenic purposes.

Cord blood is one of the richest sources of hematopoietic stem cells (HSCs), is a valuable source, and is genetically unique to the baby and family. Cord blood banking is an easy, painless, and non-invasive procedure, and if ever a need arises in the future, these stem cells could be used as powerful therapies.

Why Bank Stem Cells?

Stem cell banking can serve as a lifeline that could help treat a long list of life-threatening diseases for many years to come. It gives an opportunity to have a powerful source of cells in the event of an emergent medical therapy with no immunological rejection risk. Stem cell banking is an important decision, as it is difficult to find a matching donor at the time of urgent transplant.

To date, umbilical cord blood has been used in more than 12,000 transplantations for children and adults. stem cells have been labeled as an important biological resource that can be stored safely for future applications or diseases like Alzheimer’s, diabetes, heart and liver disease, muscular dystrophy, Parkinson’s disease, spinal cord injury, and stroke.

Public cord blood banks store donated cord blood for potential use by transplant patients. Family cord blood banks store cord blood on behalf of the client. It offers a sense of security to the family, who can use it in the event a child or family member needs it for treatment.

Babycell, a Regenerative Medical Services Pvt. Ltd., is India’s first umbilical cord blood bank for storing samples, and is an internationally accredited laboratory. The U.S. National Stem Cell Bank (NSCB), developed by the WiCell Research Institute, is a premier stem cell bank that provides hESCs to eligible scientists for use in NIHfunded research projects that meet standard quality control guidelines.

Present Scope and Future Possibilities of Stem Cell Banking :-

The easy availability of stem cells has allowed them to be used to treat as many as 130 different diseases, including leukemia, thalassemia, and neuro- and muscular-degenerative diseases. There are successful trials for cancer, diabetes, cardiac failure, multiple sclerosis, retinitis pigmentosa, spinal cord injuries, as well as for Alzheimer’s disease and Parkinson’s disease. There are more than 500 clinical trials underway at the present time. Recently, stem cell banking is also being attempted with menstrual blood cells. With the number of lifestyle disorders increasing, stem cell banking is an important option for needy patients.

Stem Cell Banks in India

Chennai-based LifeCell is the first Stem Cell Bank in India. Cryocell, a Florida-based stem cell banking facility in the U.S., has teamed up with LifeCell. Reliance Lifesciences in India has opened up collection centers in key locations in India, along with Cryobank, another pioneer in stem cell banking in India. The cost of stem cell banking differs from bank to bank.

WORLD WIDE WEB RESOURCES

Stem cell therapies offer enormous potential for the treatment of a wide range of diseases and injuries, including neurodegenerative diseases, cardiovascular disease, diabetes, arthritis, spinal cord injury, stroke, and burns. The regenerative and differentiation capacities and other potentials of stem cells make them attractive treatment modalities, but they also create challenges for the establishment of criteria to ensure development of safe and effective therapies.

Although emerging regulatory procedures try to define these criteria, the absence of appropriate legislation and enforcement, desperation for cures, media hype, and the medical tourism industry exploit differences or gaps in the regulatory framework.

There is a clear need for new research tools and strict regulatory guidelines to foster development of the types of stem cells that are potentially the most therapeutically useful and impactful. Various national guidelines were made for the use of stem cell research around the globe to improve the understanding of human health and disease, and to evolve strategies to treat serious diseases.

These guidelines address both ethical and scientific concerns to ensure responsible use of both good laboratory practices (GLP) and good clinical practice (GCP) in the area of stem cell research and therapy. However, stem cell therapies are not yet approved in India. Recently, the Indian Council for Medical Research (ICMR) and the Department of Biotechnology (DBT) formulated guidelines for stem cell research that exclude the use of embryonic cells for clinical treatment.

While the regulatory system is still in development, there are currently different mechanisms to regulate clinical translation, variable criteria used by oversight bodies for protection of human subjects, and the ability to regulate practice of medicine separate from research.

To unify and streamline the process, the National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) was created in 2009. NAC-SCRT is an interagency body created with the aim of effectively reviewing and monitoring stem cell research in India. In the United States, the FDA’s Center for Biologics Evaluation and Research, Office of Cellular, Tissue, and

Gene Therapies (CBER-OCTGT) is charged with the oversight of stem cell products as well as other biological products. In 2005 it issued the ‘‘Tissue Rules’’ (21 CFR 1271), which form the basis for regulation of all human cells, tissues, and cellular and tissue-based products (HCT/ Ps). Regarding stem cells specifically, in 2008 CBEROCTGT generated guidance for ESC-based therapies as well as considerations for preclinical safety testing and patient monitoring.

Stem cell-based products present a unique regulatory challenge because standard pharmaceutical paradigms do not wholly apply, and accordingly, stem cell therapies do not neatly fit into current regulatory categories. As a result, regulatory requirements are often unclear in their application, and therefore create uncertainty.

To better understand how stem cell therapies are faring in this regulatory environment, the International Society for Stem Cell Research (ISSCR), as well as the California Institute of Regenerative Medicine (CIRM), is working to establish a roadmap that protects patients and fosters the dramatic innovation in the stem cell field. These evolving frameworks will be informative for assessing risk tolerances in stem cell research to ensure development of safe and effective therapies for commercialization.

 

REFERENCES

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