Status clinical trial INTENS, Project ID: 668294

Leonid Schneider made this access to documents request to Research and Innovation

The request was successful.

From: Leonid Schneider

Delivered

Dear Research and Innovation,

Under the right of access to documents in the EU treaties, as developed in Regulation 1049/2001, I am requesting documents which contain the following information:

The UCL-led clinical trial INTENS and Dr Paolo De Coppi (famous for his trachea transplants with Paolo Macchiarini and Martin Birchall) announced as Work Package 5 the "transplantation of engineered intestine" in patients, to take place at UCL (London, UK) and in UCLA (California, USA). The project started in 2016, hence I request a status update on:

- any issued ethical approvals for clinical trials on patients
- any approvals issued by EMA
- any recruiting clinical trials
- any transplantations already performed

https://cordis.europa.eu/project/rcn/199...
http://www.intens.info/project/

Otherwise I wish to congratulate the EU Commission on the resounding success of another UCL regenerative medicine project, the trachea transplant TETRA led by De Coppi's partner Martin Birchall. Let us hope INTENS will be come just as successful.

Yours faithfully,
Leonid Schneider

Link to this

From: EC ARES NOREPLY


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[5]Ares(2018)4466479 - RE: access to documents request - Status clinical
trial INTENS, Project ID: 668294

Sent by ve_rtd.access documents (RTD) <[DG RTD request email]>.
All responses have to be sent to this email address.
Envoyé par ve_rtd.access documents (RTD)
<[DG RTD request email]>. Toutes les réponses doivent être
effectuées à cette adresse électronique.

Dear Mr Schneider,

 

Thank you for your request for access to documents.

 

Unfortunately, you have not indicated your postal address that is required
for registering and handling your request in line with the procedural
requirements. Please send us your full postal address at your earliest
convenience. Pending your reply, we reserve the right to refuse the
registration of your request.

 

You may, of course, use directly the [6]electronic form for entering your
request

 

Best regards,

 

 

RTD Access to documents

 

European Commission

DG Research & Innovation

Common Legal Support Service

 

ORBN

1049 Brussels/Belgium

[7][email address]

 

[8]http://ec.europa.eu/research

 

 

The European Commission is preparing a new online platform for submitting
and handling requests for public access to documents held by the
Commission based on [9]Regulation 1049/2001. All citizens and stakeholders
with an interest in this field are welcome to share their views by filling
in the [10]online questionnaire.

 

show quoted sections

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From: Leonid Schneider

Failed

Dear EC ARES NOREPLY,

I have submitted my postal address many times, this is not my first inquiry.
But here it is once again:
Taunusstr 11
63526 Erlensee
Germany

Yours sincerely,

Leonid Schneider

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From: Mail Delivery System

This message was created automatically by mail delivery software.

A message that you sent could not be delivered to one or more of its
recipients. This is a permanent error. The following address(es) failed:

[email address]
SMTP error from remote mail server after RCPT TO:<[email address]>:
host mxa-00244802.gslb.pphosted.com [185.132.180.112]:
550 5.1.1 User Unknown

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Research and Innovation


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Dear Mr Schneider,

 

Thank you for your e-mail of 28/08/2018.  We hereby acknowledge receipt of
your application for access to documents, which was registered on
30/08/2018 under reference number GestDem 2018/4723.

 

In accordance with Regulation (EC) No 1049/2001 regarding public access to
European Parliament, Council and Commission documents, your application
will be handled within 15 working days. The time limit will expire on
20/09/2018. In case this time limit needs to be extended, you will be
informed in due course.

 

Yours sincerely,

 

 

RTD Access to documents

 

European Commission

DG Research & Innovation

Common Legal Support Service

 

ORBN

1049 Brussels/Belgium

[1][email address]

 

[2]http://ec.europa.eu/research

 

 

The European Commission is preparing a new online platform for submitting
and handling requests for public access to documents held by the
Commission based on [3]Regulation 1049/2001. All citizens and stakeholders
with an interest in this field are welcome to share their views by filling
in the [4]online questionnaire.

 

 

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Research and Innovation


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Dear Mr Schneider,

 

We refer to your email of 28/8/2018, registered on 30/8/2018 under the
above mentioned reference number.

 

Your request for access to documents is currently being handled. However,
we are not in the position to complete the handling of your application
within the time-limit of 15 working days, which will expire on Thursday,
20/9/2018.

 

An extended time-limit is needed as your application concerns different
services, which had to be consulted. Therefore, we have to extend the
time-limit with 15 working days in accordance with Article 7(3) of
Regulation (EC) No 1049/2001 regarding public access to documents. The new
time-limit will expire on 11/10/2018.

 

We apologise for this delay and for any inconvenience this may cause.

 

Yours sincerely,

 

 

RTD Access to documents

 

European Commission

DG Research & Innovation

Common Legal Support Service

 

ORBN

1049 Brussels/Belgium

[1][email address]

 

[2]http://ec.europa.eu/research

 

 

The European Commission is preparing a new online platform for submitting
and handling requests for public access to documents held by the
Commission based on [3]Regulation 1049/2001. All citizens and stakeholders
with an interest in this field are welcome to share their views by filling
in the [4]online questionnaire.

 

From: RTD ACCESS DOCUMENTS
Sent: Thursday, September 6, 2018 3:47 PM
To: 'Leonid Schneider' <[FOI #5880 email]>
Subject: RE: access to documents request - Status clinical trial INTENS,
Project ID: 668294

 

Dear Mr Schneider,

 

Thank you for your e-mail of 28/08/2018.  We hereby acknowledge receipt of
your application for access to documents, which was registered on
30/08/2018 under reference number GestDem 2018/4723.

 

In accordance with Regulation (EC) No 1049/2001 regarding public access to
European Parliament, Council and Commission documents, your application
will be handled within 15 working days. The time limit will expire on
20/09/2018. In case this time limit needs to be extended, you will be
informed in due course.

 

Yours sincerely,

 

 

RTD Access to documents

 

[5]cid:image001.gif@01D44F2D.1A1CE190

European Commission

DG Research & Innovation

Common Legal Support Service

 

ORBN

1049 Brussels/Belgium

[6][email address]

 

[7]http://ec.europa.eu/research

 

 

The European Commission is preparing a new online platform for submitting
and handling requests for public access to documents held by the
Commission based on [8]Regulation 1049/2001. All citizens and stakeholders
with an interest in this field are welcome to share their views by filling
in the [9]online questionnaire.

 

 

show quoted sections

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Research and Innovation


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Dear Mr Schneider,

 

We refer to your email of 28/8/2018, registered on 30/8/2018 under the
above mentioned reference number.

 

We were not in the position to complete the handling of your application
within the extended time limit of 30 working days, which expired
yesterday, 11 October. Please be assured that we are doing our utmost to
provide you with the final reply as soon as possible.

 

Please accept our sincerest apologies for the inconveniences we may have
caused you.

 

Yours sincerely,

 

 

RTD Access to documents

 

European Commission

DG Research & Innovation

Common Legal Support Service

 

ORBN

1049 Brussels/Belgium

[1][email address]

 

[2]http://ec.europa.eu/research

 

 

From: RTD ACCESS DOCUMENTS
Sent: Tuesday, September 18, 2018 9:01 AM
To: 'Leonid Schneider' <[FOI #5880 email]>
Subject: Your application for access to documents – Ref GestDem No
2018/4723

 

Dear Mr Schneider,

 

We refer to your email of 28/8/2018, registered on 30/8/2018 under the
above mentioned reference number.

 

Your request for access to documents is currently being handled. However,
we are not in the position to complete the handling of your application
within the time-limit of 15 working days, which will expire on Thursday,
20/9/2018.

 

An extended time-limit is needed as your application concerns different
services, which had to be consulted. Therefore, we have to extend the
time-limit with 15 working days in accordance with Article 7(3) of
Regulation (EC) No 1049/2001 regarding public access to documents. The new
time-limit will expire on 11/10/2018.

 

We apologise for this delay and for any inconvenience this may cause.

 

Yours sincerely,

 

 

RTD Access to documents

 

European Commission

DG Research & Innovation

Common Legal Support Service

 

ORBN

1049 Brussels/Belgium

[3][email address]

 

[4]http://ec.europa.eu/research

 

 

The European Commission is preparing a new online platform for submitting
and handling requests for public access to documents held by the
Commission based on [5]Regulation 1049/2001. All citizens and stakeholders
with an interest in this field are welcome to share their views by filling
in the [6]online questionnaire.

 

From: RTD ACCESS DOCUMENTS
Sent: Thursday, September 6, 2018 3:47 PM
To: 'Leonid Schneider' <[7][FOI #5880 email]>
Subject: RE: access to documents request - Status clinical trial INTENS,
Project ID: 668294

 

Dear Mr Schneider,

 

Thank you for your e-mail of 28/08/2018.  We hereby acknowledge receipt of
your application for access to documents, which was registered on
30/08/2018 under reference number GestDem 2018/4723.

 

In accordance with Regulation (EC) No 1049/2001 regarding public access to
European Parliament, Council and Commission documents, your application
will be handled within 15 working days. The time limit will expire on
20/09/2018. In case this time limit needs to be extended, you will be
informed in due course.

 

Yours sincerely,

 

 

RTD Access to documents

 

[8]cid:image001.gif@01D44F2D.1A1CE190

European Commission

DG Research & Innovation

Common Legal Support Service

 

ORBN

1049 Brussels/Belgium

[9][email address]

 

[10]http://ec.europa.eu/research

 

 

The European Commission is preparing a new online platform for submitting
and handling requests for public access to documents held by the
Commission based on [11]Regulation 1049/2001. All citizens and
stakeholders with an interest in this field are welcome to share their
views by filling in the [12]online questionnaire.

 

 

show quoted sections

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From: Leonid Schneider

Delivered

Dear Research and Innovation,

I am afraid I must insist on a reply. The affair of trachea transplants performed at UCL and GOSH by the project head Paolo De Coppi and his colleagues is now very much a hot issue.
https://forbetterscience.com/2018/02/01/...
Your delays appear artificial in order to avoid public scrutiny of your funding decisions and your irresponsible attitude towards patients, as you already amply demonstrated with another clinical trial you fund (led also by UCL), by repeatedly denying me and prospective patients any information on TETRA.
https://forbetterscience.com/2018/03/26/...
I therefore request an internal review because I suspect that the real reason for the delay is an attempt to find ways to avoid answering my request altogether.
Yours faithfully,

Leonid Schneider

Link to this

From: EC ARES NOREPLY


Attachment Schneider.pdf
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Please find attached document Ares(2018)5332580 regarding your access to documents request - Status clinical trial INTENS, Project ID: 668294 sent by Mr PAQUET Jean-Eric on 17/10/2018.

-------------------------------------------------------------------------------------------------------------
Note: This e-mail was automatically generated by the European Commission's central mail registration system.
Replies by e-mail must be addressed to the original sender PAQUET Jean-Eric (mailto:[email address]).
Remarque : Cet e-mail a été généré automatiquement par le système d'enregistrement central du courrier de la Commission européenne.
Toute réponse éventuelle par e-mail doit être adressée à l'expéditeur en personne, à savoir PAQUET Jean-Eric (mailto:[email address]).

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From: Leonid Schneider

Delivered

Dear Research and Innovation,

Please pass this on to the person who reviews confirmatory applications.

I am filing the following confirmatory application with regards to my access to documents request 'Status clinical trial INTENS, Project ID: 668294'.

I am puzzled as to why the EU Commission declares:
"The Horizon 2020 project INTENS (INtestinal Tissue ENgineering Solution) does not have
any deliverables related to clinical trials on patients under Regulation (EU) No 536/2014 of
the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal
products for human use, and repealing Directive 2001/20/EC. "

A visit to the Consortium website provides this Workplan:
http://www.intens.info/project/workplan/
http://www.intens.info/wp-content/upload...
The work package 5 is titled: "Transplantation of engineered intestine". I reached out to members of the consortium and received no information about that work package, hence my FOIA request to the EU Commission.
One of the goals of INTENS is defined: "Engineering intestine for transplantation"
Cordis website declares:
"The work is designed to lead directly to a clinical trial for the application of the optimal protocol for tissue-engineered intestine."

Therefore I request the EU Commission to study the original grant proposal, find the section about the scheduled clinical applications, contact the Consortium lead at UCL and inform me on any clinical applications of INTENS bowel replacements which already took place or are scheduled either in a clinical trial or as compassionate use.

A full history of my request and all correspondence is available on the Internet at this address: https://www.asktheeu.org/en/request/stat...

Yours faithfully,

Leonid Schneider

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Research and Innovation


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Dear Leonid Schneider,
Thank you for your email dated 17 October 2018, by which you request,
pursuant to Regulation No 1049/2001 regarding public access to European
Parliament, Council and Commission documents, a review of the position
taken by DG RTD.
In order to allow us to properly identify the file for which you are
requesting a review, please confirm and provide us with our reference
number (GESTDEM 2018/…) within the same email in which you request the
review.
Please be informed that the answer to a confirmatory application is a
formal Commission decision that will be notified to the applicant by
express delivery. We kindly offer you also the possibility to provide us a
contact phone number (by email to [email address]), so that the
external delivery service can contact you in case of absence.
Please note that the Commission will not use your phone number for any
other purpose than for informing the delivery service.
 
Best regards,
 
Gitte Louise Olsen
Access to documents team
 
European Commission
Secretariat-General
Unit C1 – Transparency, Document Management &
Access to Document
Office address BERL 05/315
+32 2 995 63 26
[1][email address]
 
 
 
 
From: RTD ACCESS DOCUMENTS
Sent: Thursday, October 18, 2018 9:10 AM
To: SG ACCES DOCUMENTS <[email address]>
Subject: FW: Internal review of access to documents request - Status
clinical trial INTENS, Project ID: 668294
 
From: Leonid Schneider <[2][FOI #5880 email]>
Sent: Wednesday, October 17, 2018 9:03 PM
To: RTD ACCESS DOCUMENTS <[3][email address]>
Subject: Internal review of access to documents request - Status clinical
trial INTENS, Project ID: 668294
 
Dear Research and Innovation,
 
Please pass this on to the person who reviews confirmatory applications.
 
I am filing the following confirmatory application with regards to my
access to documents request 'Status clinical trial INTENS, Project ID:
668294'.
 
I am puzzled as to why the EU Commission declares:
"The Horizon 2020 project INTENS (INtestinal Tissue ENgineering Solution)
does not have
any deliverables related to clinical trials on patients under Regulation
(EU) No 536/2014 of
the European Parliament and of the Council of 16 April 2014 on clinical
trials on medicinal
products for human use, and repealing Directive 2001/20/EC. "
 
A visit to the Consortium website provides this Workplan:
[4]http://www.intens.info/project/workplan/
[5]http://www.intens.info/wp-content/upload...
The work package 5 is titled: "Transplantation of engineered intestine". I
reached out to members of the consortium and received no information about
that work package, hence my FOIA request to the EU Commission.
One of the goals of INTENS is defined: "Engineering intestine for
transplantation"
Cordis website declares:
"The work is designed to lead directly to a clinical trial for the
application of the optimal protocol for tissue-engineered intestine."
 
Therefore I request the EU Commission to study the original grant
proposal, find the section about the scheduled clinical applications,
contact the Consortium lead at UCL and inform me on any clinical
applications of INTENS bowel replacements which already took place or are
scheduled either in a clinical trial or as compassionate use.
 
A full history of my request and all correspondence is available on the
Internet at this address:
[6]https://www.asktheeu.org/en/request/stat...
 
Yours faithfully,
 
Leonid Schneider
 
 
 
-------------------------------------------------------------------
Please use this email address for all replies to this request:
[7][FOI #5880 email]
 
This message and all replies from Research and Innovation will be
published on the AsktheEU.org website. For more information see our
dedicated page for EU public officials at
[8]https://www.asktheeu.org/en/help/officers
 
 
-------------------------------------------------------------------
 
 

References

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2. mailto:[FOI #5880 email]
3. mailto:[email address]
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5. http://www.intens.info/wp-content/upload...
6. https://www.asktheeu.org/en/request/stat...
7. mailto:[FOI #5880 email]
8. https://www.asktheeu.org/en/help/officers

Link to this

From: Leonid Schneider

Delivered

Dear Research and Innovation,

here is the requested number: GestDem 2018/4723.
My phone number is: 0049-1573-6614791

Yours faithfully,

Leonid Schneider

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Research and Innovation


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Dear Leonid Schneider,
Thank you for your email dated 18 October 2018, by which you request,
pursuant to Regulation No 1049/2001 regarding public access to European
Parliament, Council and Commission documents, a review of the position
taken by DG RTD in reply to your initial application GESTDEM 2018/4723.
We hereby acknowledge receipt of your confirmatory application for access
to documents which was registered on 22/10/2018 (Ares(2018)5405471).
Your application will be handled within 15 working days (14/11/2018). In
case this time limit needs to be extended, you will be informed in due
course.
Please be informed that the answer to your confirmatory application is a
formal Commission decision that will be notified to you by express
delivery.
 
Best regards,
 
Gitte Louise Olsen
Access to documents team
 
European Commission
Secretariat-General
Unit C1 – Transparency, Document Management &
Access to Document
Office address BERL 05/315
+32 2 995 63 26
[1][email address]
 
 

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From: EC ARES NOREPLY


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[5]Ares(2018)5774370 - Your confirmatory application for access to
documents under Regulation (EC) No 1049/2001 – GESTDEM 2018/4723

Sent by ve_sg.accessdoc (SG) <[email address]>. All responses have
to be sent to this email address.
Envoyé par ve_sg.accessdoc (SG) <[email address]>. Toutes les
réponses doivent être effectuées à cette adresse électronique.

Dear Mr Schneider,

 

I refer to your email of 19 October 2018, registered on 22 October 2018,
through which you submit a confirmatory application in accordance with
Article 7(2) of Regulation (EC) No 1049/2001 regarding public access to
European Parliament, Council and Commission documents ('Regulation
1049/2001').

 

Your confirmatory application is currently being handled. Unfortunately,
we have not yet been able to gather all the elements we need to carry out
a full analysis of your request in order to take a final decision and,
therefore, we are not in a position to reply to your confirmatory request
within the prescribed time limit expiring 14 November 2018.

 

Consequently, we have to extend the deadline for handling it by another 15
working days in accordance with Article 8(2) of Regulation 1049/2001. The
new deadline expires on 5 December 2018.

 

We apologise for any inconvenience this may cause.

 

Martine Fouwels

Deputy Head of Unit

 

[6]Flag

European Commission

Secretariat General

Unit C1 (Transparency, Document Management and Access to Documents)

 

References

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2. file:///tmp/cid:editdata.mso
3. file:///tmp/~~themedata~~
4. file:///tmp/~~colorschememapping~~
5. https://webgate.ec.testa.eu/Ares/ext/doc...

Link to this

From: EC ARES NOREPLY


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Attachment C 2018 7901 F1 DECISION LETTER EN V2 P1 1002438.pdf
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[5]Ares(2018)5962168 - Confirmatory decision taken on your request for
access to documents registered under Gestdem number 2018/4723

Sent by ve_sg.accessdoc (SG) <[email address]>. All responses have
to be sent to this email address.
Envoyé par ve_sg.accessdoc (SG) <[email address]>. Toutes les
réponses doivent être effectuées à cette adresse électronique.

Dear Sir,

 

Please find attached an advance information copy of the confirmatory
decision taken on your request for access to documents registered under
Gestdem number 2018/4723, adopted on 20/11/2018 in the above-mentioned
case.

 

Please note that the Secretariat General of the European Commission will
proceed with the formal notification of the decision in the coming days.

 

This advance copy is solely sent for your information and is not the
formal notification of the confirmatory decision.

 

Yours sincerely,

Carlos Remis
SG.C.1
Transparence
Berl. 05/315

 

 

References

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4. file:///tmp/~~colorschememapping~~
5. https://webgate.ec.testa.eu/Ares/ext/doc...

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