Michael Cea, an analyst/advocate, submitted comments on the ISSCR 2015 Draft Guidelines for Stem Cell Science and Clinical Translation. Some of his general comments included: (1) suggesting consolidating the informed consent sections for research and therapeutic use; (2) balancing language between deriving knowledge and prudent research; (3) providing an interactive online/offline version of the final draft. Cea also provided over 30 specific comments and recommendations, primarily addressing informed consent processes, definitions, clinical trial guidelines, and communication standards.

1. Comments on the ISSCR 2015 Draft Guidelines for Stem Cell Science and Clinical Translation
Submitted by:
General Comments
Affiliation:
Position:
Comments are now being accepted by email through 10 September, 2015. Email your
comments to info@isscr.org with the subject line “Comments on ISSCR Guidelines.” We
encourage you to provide "general comments" on the guidelines in the box below, as
well as more specific comments and suggestions on the following pages.
Open: "DRAFT Guidelines for Stem Cell Science and Clinical Translation."
Page 1 of 11 2015-08-05
Michael Cea
@msemporda
Analyst / Advocate
I've taken the liberty of commenting on the Draft Guidelines as a patient advocate.
The overall takeaway from reading the document is that it has been constructed with considerable thought and
professionalism. The document will no doubt serve the community well as the envisioned reference tool it is
intended to be.
Some general comments:
- The informed consent aspect of the draft notes makes research recommendations and then a short sub-section
later talks about therapeutic use consent. My feeling is that it would be more efficient if the two types of informed
consent were consolidated in one sub-section with the use of highlights, separators/formatting or the like for specific
notes pertaining to each. This would allow for a global perspective on the requirements, clarify what the intent is for
each, while allowing for layout referencing of the differences and addition of unique elements considered important.
- There seems somewhat of a divide in the language used from the stated intent to derive knowledge for patient
solutions to the need to be conservative and prudent in the approach to focused evidence based research. I believe
there will be a perception benefit in projecting a macro balance on this topic throughout the guidelines, especially in
the areas of informed consent and science communication.
- Often when presenting such guidance it's important to allow for easy access to the pertinent sections. In that
regard I would suggest an interactive version of the final draft in both an off-line & on-line format - the on-line version
being more dynamic (e.g. functionality & supplementary content).
Cheers

2. Comments on the ISSCR 2015 Draft Guidelines for Stem Cell Science and Clinical Translation
Submitted by:
Affiliation:
Position:
Page # Line # Section #/ ISSCR Language Comments/Recommendations
Page 2 of 11 2015-08-05
Michael Cea
@msemporda
Analyst / Advocate
7 1>7
2.1.3.2 You may wish to consider mentioning the issue of the definition of
what constitutes an Human Embryo in regard to global jurisdictions
and interpretation, considering non-viability & non-fertilized
embryo-like structures. It would seem that difference considerations
may be warranted during the SCRO process and therefore
indicating such in the document may be relevant.
8 12
2.1.3.3 Consideration of additional areas may be
warranted:
- Synthetic uterus used ex-vivo implanted with
viable Human Embryos
- Reprogrammed human somatic cells to
totipotency for embryo creation experiments
- Use of both types of reprogrammed synthetic
human gametes from the same or different hosts
which are then used together to create synthetic
embryos
8 4>8
2.1.3.3 Also I would add for safety the possibility of in-vivo
9 30>33
2.2.2 The issue of consent extends to the type of
research that is proposed - the creation of viable
human embryos or non-viable (re: my comment in
the first box above). Perhaps this is a salient point
for donors to consider and allow for in the consent
process.
10 10
2.2.3 Specific URL and/or as an Appendices?
10 18
2.2.3.ii May be destroyed rather than the definitive will in
certain cases
10 All
2.2.3 & 2.2.6 In addition to my general comments on the topic
there may be greater utility in encouraging the
blanket consent option for translational/clinical
research flexibility on cell line choice moving
forward. Returning for additional consent seems
unnecessary & burdensome if there is a consent
option for full approval in the donor disclosure. Also
is there a need to guide on the use of therapeutic
grade cell lines in translational research for ease of
regulatory approvals?

3. Comments on the ISSCR 2015 Draft Guidelines for Stem Cell Science and Clinical Translation
Submitted by:
Affiliation:
Position:
Page # Line # Section #/ ISSCR Language Comments/Recommendations
Page 3 of 11 2015-08-05
Michael Cea
@msemporda
Analyst / Advocate
10 30>37
2.2.3.vi bit confusing - perhaps a rewording w/ shorter sentences
10 38>43
2.2.3.vii as required by local law
11 3>5
2.2.3.x in a therapeutic donation it may benefit the donor
or may lead to use of donor cells for therapeutic
purposes in a commercial setting
11 25
2.2.3.xvii perhaps consider adding > that the donor will be
contacted for written approval should there ever be
a request by a recipient of the donated tissue/cells
for the donor's identity prior to any data disclosure
(adoption precedent)
13 46
2.2.7.v the use of the word solely limits the scope of the
donated oocyte - wouldn't a broader scope be
better as there may be uses beyond research
16 9
2.3.3.xi perhaps an additional sub-section that addresses
the issue of a feedback channel through primary
researchers or others that collect bio-materials for
personal data disclosure consent in the event a
recipient of donor cells requests contact with the
donor
17 43
2.4.1 consider an addition, if not already incorporated, to
the membership by-laws of ISSCR which requires
acceptance and good faith adherence to the
guideline standards set periodically by the society.
A membership terms update would serve the
purpose.

4. Comments on the ISSCR 2015 Draft Guidelines for Stem Cell Science and Clinical Translation
Submitted by:
Affiliation:
Position:
Page # Line # Section #/ ISSCR Language Comments/Recommendations
Page 4 of 11 2015-08-05
Michael Cea
@msemporda
Analyst / Advocate
21 45
3.1.2.4 words "be developed" should be reconsidered in light of sentence
22 30
3.2 "and reported" are unnecessary
30 42
3.3.2.4 burden is one criteria for competitive assessment
yet aren't there others, such as effect comparison
30/31 45>2
3.3.2.4 seems short & unfinished as a sub-section that
represents an important goal of the work
31 10>15
3.3.2.5 should the guidelines not promote clinical trial
enrollment free of commercial consideration
requirements of patients selected. As currently
worded the weight is on the patient unless they are
unable to pay
31 35>36
3.3.2.7 perhaps a need to rephrase sentences for clarity of
meaning
32
3.3.2.9 while acceptable it may be appropriate to include
preferable guidance that trials be funded publicly or
by industry to maintain design & structural integrity

5. Comments on the ISSCR 2015 Draft Guidelines for Stem Cell Science and Clinical Translation
Submitted by:
Affiliation:
Position:
Page # Line # Section #/ ISSCR Language Comments/Recommendations
Page 5 of 11 2015-08-05
Michael Cea
@msemporda
Analyst / Advocate
35 12>21
3.3.6 The primary mission statements would suggest that there isn't such
a divide between scientific research and clinical application for the
ultimate benefit of patients in need. A noted difference between
medical procedures and research is warranted while acknowledging
perhaps the goal of all research in furthering the field towards
patient outcomes, in keeping with the stated mission.
42 31
4.1 I would suggest more than care is needed >
diligence.
42
4.1 Generally efforts should be made to extend
knowledge to the public in as many ways as
possible using layman language while maintaining
a strict adherence to the disclosure of stage of
research and translational timelines to ensure
expectations are managed. Perhaps a stage /
time-line rating system should be developed and
implemented broadly using a scaled logo id and/or
# system when communicating science. This would
clarify in the publics' mind the stage development
of the science report.
43 7
4.2 The use of "not," while clarifying a misleading
public impression, doesn't convey the correct
message. Perhaps something like "while furthering
the translational development for possible
therapeutic benefit"
43 20
4.2 Add perhaps "while acknowledging the intent to
seek a therapeutically beneficial product through
clinical investigation"
43 20
4.2. Add perhaps a paragraph on patients, families and
advocacy groups being provided with appropriate
guidelines on communication issues and their
responsibility to the scientific investigative process,
with specific reference to ad-hoc reporting directly
through social media or to mainstream media
outlets & other interested parties.
44
5.1 Add communication standards

6. Comments on the ISSCR 2015 Draft Guidelines for Stem Cell Science and Clinical Translation
Submitted by:
Affiliation:
Position:
Page # Line # Section #/ ISSCR Language Comments/Recommendations
Page 6 of 11 2015-08-05
Michael Cea
@msemporda
Analyst / Advocate

7. Comments on the ISSCR 2015 Draft Guidelines for Stem Cell Science and Clinical Translation
Submitted by:
Affiliation:
Position:
Page # Line # Section #/ ISSCR Language Comments/Recommendations
Page 7 of 11 2015-08-05
Michael Cea
@msemporda
Analyst / Advocate

8. Comments on the ISSCR 2015 Draft Guidelines for Stem Cell Science and Clinical Translation
Submitted by:
Affiliation:
Position:
Page # Line # Section #/ ISSCR Language Comments/Recommendations
Page 8 of 11 2015-08-05
Michael Cea
@msemporda
Analyst / Advocate

9. Comments on the ISSCR 2015 Draft Guidelines for Stem Cell Science and Clinical Translation
Submitted by:
Affiliation:
Position:
Page # Line # Section #/ ISSCR Language Comments/Recommendations
Page 9 of 11 2015-08-05
Michael Cea
@msemporda
Analyst / Advocate

10. Comments on the ISSCR 2015 Draft Guidelines for Stem Cell Science and Clinical Translation
Submitted by:
Affiliation:
Position:
Page # Line # Section #/ ISSCR Language Comments/Recommendations
Page 10 of 11 2015-08-05
Michael Cea
@msemporda
Analyst / Advocate

11. Comments on the ISSCR 2015 Draft Guidelines for Stem Cell Science and Clinical Translation
Submitted by:
Affiliation:
Position:
Page # Line # Section #/ ISSCR Language Comments/Recommendations
Page 11 of 11 2015-08-05
Michael Cea
@msemporda
Analyst / Advocate