The document discusses national guidelines for stem cell research in India from 2013 and draft guidelines from 2017. The 2013 guidelines only approved stem cell transplantation for blood disorders and required all other uses to be in clinical trials. The 2017 draft guidelines recognize potential benefits of stem cells but stress the need for safety and efficacy data before clinical use. It warns against unregulated stem cell therapy due to lack of evidence, patient exploitation, and safety risks like tumor growth. The draft provides recommendations for quality control of cell processing and manufacturing.

2. ESHRE Human Reproduction Keynote
lecture by Carlos Simon, 2017

13. For treating infertility
•Ovarian failure
•Endometrial atrophy
•Azoospermia
•Repeated implantation
failure

14. National Guidelines for Stem Cell
Research

15. National Guidelines for Stem Cell
Research - 2013
• There are no approved indications for stem cell
therapy other than Haematopoietic Stem Cell
Transplantation (HSCT) for haematological
disorders. All stem cell therapies other than the
above shall be treated as investigational and may
be conducted only in the form of clinical trials
after obtaining necessary regulatory approvals.
• Use of stem cells for any other purpose outside
the domain of clinical trials will be considered
unethical and hence not permissible.

16. Draft National Guidelines for Stem
Cell Research 2017
• Use of stem cells in regenerative medicine
holds promise for improving human health by
restoring the function of cells and tissues
damaged due to degeneration and/or injury.
• Like all other medical innovations, emerging
research on stem cells and translational
biology not only requires a sound scientific
rationale, but also strict adherence to ethical,
legal and social issues.

17. Draft National Guidelines for Stem
Cell Research 2017
• Indiscriminate use of stem cells without
establishing efficacy for therapy and before
obtaining adequate data on their safety has
created unprecedented difficulties related to
therapeutic profligacy with vulnerable patients
getting exploited.
• In recent years, the use of stem cells in clinical
indications that has not yet been substantiated
scientifically, has posed serious problems to
patients in terms of their well-being and
financial exploitation.

18. Draft National Guidelines for Stem
Cell Research 2017
• Potential dangers
• Tumorigenicity of stem cells considering their
capacity for unlimited proliferation
• Possibility of genomic changes arising during
in vitro manipulations
• Limitations related to immunological tissue
incompatibility between individuals

19. Draft National Guidelines for Stem
Cell Research 2017
• The rigor of quality control and quality assurance
(QC/QA) for the product development including cell
processing and manufacturing stages is critical
• This is mandatory for all clinical trials. These include
cell viability, final cell population (using CD
markers),stability and requirements for release.
• The infrastructure facility shall be duly accredited or
certified by CDSCO or 204 NABL, and file the CMC
(Chemistry, Manufacturing and Control) documents for
regulatory purposes and necessary approvals.

23. Backlash

25. The elephant in the room
• None of us will change what we are
doing!
• We all have our personal prejudices

26. Trigger happy doctor
• We like doing things - " itchy " fingers
• You feel good because you offered
treatment – even if it is useless and
unproven
• Your patient is happy – she feels you
have “treated “ her
• You can charge a lot more, as compared
to doing nothing !

27. Why it’s easy to fool
doctors
• Personal experience - Small numbers, no
controls, no followup
• Patients change doctors all the time.
Only the success stories come back with
chocolates !
• Reinforces your bias – the easiest person
to fool in the world is yourself

28. Why it’s easy to fool doctors
• Eminence based medicine – based
on "my extensive clinical
experience”.
• Experts fudge numbers – they lie !
• Sponsored by stem cell companies
who want to sell their products

34. Doctor vs Doctor

39. ‘From inability to let well alone
From too much zeal for the new and contempt for
what is old
From putting knowledge before wisdom, science
before art, and
Cleverness before common sense;
From treating patients as cases;
And from making the cure of the disease more
grievous than the
Endurance of the same, Good Lord, deliver us.’
Sir Robert Hutchison

41. Taking patients and doctors for a
ride
• The people selling your patients stem cell treatments
want your patient’s money.
• They will do their best to convince you that their
treatment is safe and effective.
• The more convincing they are then the more money
they make.
• The bottom line is that the sellers of dubious stem cell
treatments are generally in it for the big bucks.
• Some of these providers truly believe stem cells are
helpful, but you’ll never see them offering to give
patients the cells at cost. These are instead very much
for-profit operations.