ESHRE Human Reproduction Keynote lecture by Carlos Simon, 2017

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

failure

National Guidelines for Stem Cell Research

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.

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.

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.

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

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.

Backlash

The elephant in the room

• None of us will change what we are doing!• We all have our personal prejudices

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 !

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

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

Doctor vs Doctor

‘From inability to let well aloneFrom too much zeal for the new and contempt for

what is oldFrom putting knowledge before wisdom, science

before art, andCleverness before common sense;From treating patients as cases;And from making the cure of the disease more

grievous than theEndurance of the same, Good Lord, deliver us.’Sir Robert Hutchison

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.