Thought I'd drop in as been a while. Had some time to kill &...

Thought I'd drop in as been a while.

Had some time to kill & have a quick scrounge around to catch up where u at.

I see still fairly status quo atm & in that frustration phase of the company not feeding out much info...like a lot of them at times.

Anyway, noticed someone posted another hospital on board and was checking that out but came across this update which appears from 17 Oct - you guys may have seen or maybe know more about or it maybe nothing.

The actual change is the "ipd sharing stmt" (my bold) which is a green cell (on the site - link below) and the key says where green is "added". All seems to be about "sharing or not sharing" something so may be worth a watch for any additions / explanations?

GL

https://clinicaltrials.gov/archive/NCT02923375/2017_10_17/changes

	Before(Updated 2017_06_07)
1	After(Updated 2017_10_17)
2	1
3	2
4	3	2016-10-03	2016-10-03
5	4	2017-06-07	2017-10-16
6	5

Protocol definition https://prsinfo.clinicaltrials.gov/definitions.html

12. IPD Sharing Statement

• mce-anchorPlan to Share IPD
  Definition: Indicate whether there is a plan to make individual participant data (IPD) collected in this study, including data dictionaries, available to other researchers (typically after the end of the study). Select one.
  • Yes: There is a plan to make IPD and related data dictionaries available.
  • No: There is not a plan to make IPD available.
  • Undecided: It is not yet known if there will be a plan to make IPD available.
  • • IPD Sharing Plan Description
      Definition: If Plan to Share IPD is "Yes," briefly describe what specific individual participant data sets are to be shared (for example, all collected IPD, all IPD that underlie results in a publication). If the Plan to Share IPD is "No" or "Undecided," an explanation may be provided for why IPD will not be shared or why it is not yet decided.
      Limit: 1000 characters.
  • • If Plan to Share IPD is "Yes," provide the following information.
    • IPD Sharing Supporting Information Type
      Definition: The type(s) of supporting information that will be shared, in addition to the individual participant data set and data dictionaries for the IPD itself. Select all that apply.
      • Study Protocol
      • Statistical Analysis Plan (SAP)
      • Informed Consent Form (ICF)
      • Clinical Study Report (CSR)
      • Analytic Code
  • • IPD Sharing Time Frame
      Definition: A description of when the IPD and any additional supporting information will become available and for how long, including the start and end dates or period of availability. This may be provided as an absolute date (for example, starting in January 2025) or as a date relative to the time when summary data are published or otherwise made available (for example, starting 6 months after publication).
      Limit: 1000 characters.
  • • IPD Sharing Access Criteria
      Definition: Describe by what access criteria IPD and any additional supporting information will be shared, including with whom, for what types of analyses, and by what mechanism. Information about who will review requests and criteria for reviewing requests may also be provided.
      Limit: 1000 characters.
  • IPD Sharing URL
    Definition: The web address, if any, used to find additional information about the plan to share IPD.
    Limit: 3999 characters.

Also saw this slide presso - was back from Mar 2017 but ref made to CYP plus couple other stem Co's. The presenter saw fit to highlight a nice little CYP snippet. Just a throw in fyi

"Clinical Applications of Mesenchymal Stromal Cells John Girdlestone PhD Stem Cells and Immunotherapies NHS Blood and Transplant, Oxford John Radcliffe Hospital"

https://www.google.com.au/url?sa=t&...lestone.pdf/&usg=AOvVaw1HDO0mnQfGJq2jLGccple2