Clinical Trial Application at Germany

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               Planned or ongoing clinical trials regarding spinal cord injury.
                            Update August 26, 2006. - DRAFT
By : Corinne Jeanmaire, SCI patient since 2001, based upon input from Alarme [Huge thanks to T.Delrieu] and
Carecure members. In case of remarks/input/corrections needed, please mail

IMPORTANT Remark : Programs are listed without any order of preference. Also, some treatments are referred
to as ‘clinical trial’ by their initiator without any public evidence of their scientific character and might in reality
merely be experimental treatment. More-over, most of those are ‘planned’ but might not get the necessary approval
to actually start. Last but not least, if you plan to sign up for any of those, please remember that even scientifically
organized clinical trials can be dangerous ! This is in no way an endorsement. Before enrolling into any trial,
please check if the prior phases of animal trial do guarantee minimum safety level. Some of the trials below may
include risks as animal trial might have been insufficient [possibly in time and number of subjects]. Think of tumor
risks, for example.


1)      Chronic SCI [ASIA C or D] : HP-184-Sanofi-Aventis - end 2006

Update August 2006: ????????? Info is being checked by French Association Alarme members.

Update May 2006:
Phase 3 trial is expected to start end of 2006 [November 2006]. France is expected to take part in the trial.
Source of information : Dr Douillet, Neurological research of Sanofi-Aventis, info reported via a member of

Contacts :
174, av. de France
75013 PARIS

Tel : (33) 1 53 77 40 00

Update end 2005:
The pharmaceutical company Sanofi-Aventis ordered a study concerning the HP-184 molecule [agonist of the
adreno-receptor alpha-1A]. That molecule is going to enter into phase III clinical trial. It will be applied to patients
with a chronic and incomplete spinal cord injury [Asia C or D].

That molecule showed a real functional efficacy on incomplete injuries during phase II with light secondary effects.
One patient declared that she regained full sensation on her entire body and most her muscles status increased from
level 1 to level 4 or 5. The secondary effects were: nausea, headaches, general tiredness.
More info on the company‟s website :

More info on Alarme [French only] :,25.0.html
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2)      Acute SCI [less than 10/15 days] : Anti-Nogo. NOVARTIS - Dr Schwab-Zwitzerland- 2006

Update August 15, 2006:

- status [August 15, 06]: Patients are being recruited in Germany and Switzerland. At least 1 patient is already
getting treatment now in Germany.

Extract from July 2006 -[translated
into English] : « Novartis has started some clinical trials on paraplegic patients further to successful
experiments on apes . It is an important step for the research carried out by the Zurich and Fribourg
universities whose results have been published last week in the magazine „Nature Medicine‟.
Novartis carries out this trial in co-operation with the Centre de recherche sur la Moelle Epiniere of the
Zurich University and other European and American specialists. […]

The initial phase of this trial consists in inserting a small pump within the newly injured to inject the
AntiNogo into their spine on regular basis.

-next step: “according to Novartis, the next step will be, if everything goes fine, in the spring of 2007. It will
consists in assessing both safety and efficacy of the treatment by about 100 patients”.

-Contact : Martin E. Schwab - Chair for Neuroscience
Brain Research Institute - University of Zurich and Dept. of Biology, ETH Zurich
Winterthurerstr.190 - 8057 Zurich, Switzerland
Phone: 0041 44 635 33 30
Fax: 0041 44 635 33 03
- other contacts:
- Université de Zurich :

- Université de Fribourg :

- Les recherches de Martin Schwab :

- Le laboratoire Rouiller, Université de Fribourg :

- Novartis :
- Source of info [july06] :
and Alarme [French only] :,50.0.html#lastPost

Update March 2006:
Phase 1 is ongoing.

Update end 2005:
Dr Martin E. Schwab [Zurich University] will start a limited phase I of clinical trial in January 2006, and might
continue with an extensive phase II, depending on the outcome of Phase I, later in 2006.
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The clinical experiments with Anti Nogo-A antibodies will be carried out in co-operation with Novartis in the
„European Clinical Spinal Cord Injury Network‟, which is coordinated by Dr Armin Curt and Pr Volker Dietz
[Zurich]. Pr Bernard Bussel in Garches [Paris] also belongs to that network. First trials take place in Zurich and

Inclusion criteria : patients ASIA A or B, but with a anatomically incomplete injury [remark : a great majority of
patients, even when rated ASIA A, are anatomically incomplete, ie their spinal cord is not fully trans-sected].

More info on :

3)      Acute SCI [less than 15 days] – Rho Antagonists – BioAxone Therapeutic- 2006

Update August 2006:
- Status: patient recruitment for phase I/IIa is over [37 patients from 9 centers in USA and Canada].
- Next step : Results of phase I/IIa to be published during autumn 2006. Phase IIb/III to be launched by end 2006?

- Contact: Dr Frank Bobe BioAxone Thérapeutique Inc., (514) 282-9990-
- Source of info:

Update: end 2005:
The company BioAxone Therapeutic, founded in April 2000 and based in Montreal [Canada], is going to finish the
phase I/IIa of the clinical trial for acute SCI by June 2006 and is going to launch a phase IIb/III of the trial by end
Since the beginning of the trial phase I/IIa in February 2005, 20 patients were registered in one of the 10 American
and Canadian clinical sites
BioAxone uses a molecule which was developed by Dr Lisa Mc Kerracher, the Cethrin® , which is a recombinant
protein which acts as a Rho antagonist to promote neuroregeneration and neuroprotection in the Central Nervous
System [CNS] .
Source :
More info on Alarme [French and English] :,48.0.html

4)      Acute and chronic SCI : China SCI clinical trial network – W Young PhD. 2007

Update: August 2006:
To be checked with dr Wise Young.
-Next step:
-Source of info:

Update : March 2006:

-Status: The project spreads on various years and aims at testing various combination therapies including the
transplant of OEG cells or stem-cells and neurotrophic compounds and/or anti-inhibitors of the axonal growth.

“This is a network of about 16 leading spinal cord injury centers in China. Patients are being recruited for 6 month
observations and will be randomized to lithium. A trial is being planned for 2007 where the patients will receive
umbilical cord blood cell transplants and randomized to lithium or placebo.
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• Fetal olfactory ensheathing glia. These are being transplanted into patients with chronic spinal cord injury by at
least three hospitals: Dr. Hungyun Huang's, the Beijing Army General Hospital, and the Sun Yatsen Memorial
Hospital in Guangzhou.
• Fetal Schwann cell transplants. These are being transplanted into patients with subacute (2 weeks) and chronic
spinal cord injury. Over 120 patients have received these transplants to date.
• Intrathecal infusion of autologous bone marrow stem cells. These are being done at the Henan People's Provincial
Hospital in Zhengzhou. Over 200 patients have received these cells during the subacute phase.
• Autologous Schwann cell transplants into people with chronic spinal cord injury. These have been done already
in about 10 patients with chronic spinal cord injury at Tienjian University.” Dito W. Young

Source of info: post by Dr Wise Young, March 2006 in

5)      ACUTE AND CHRONIC SCI – CHINA [other than ‘China clinical trial Network”] – Ongoing.

Update August 2006:
-status [May 2006]:
• Shi Shan Hospital, Dr. Hongyun Huang, fetal olfactory ensheathing glia,
chronic spinal cord injury.
• Beijing Army General Hospital, Dr. Tianshen Sun, fetal olfactory ensheating
glia, chronic spinal cord injury.
• People's Provincial Hospital of Henan, Zhengzhou, Dr. Zheng, intrathecal
injection of autologous cultured bone marrow stem cell (CD34, CD44)
• Chengdu Army General Hospital, Kunming, Yunnan, Dr. Fei Zhu, intraspinal
transplantation of fetal Schwann cells, subacute (2 weeks) spinal cord injury.
• Changhai Hospital (Second Military Hospital), Shanghai, Dr. Zhang, peripheral
nerve bridging from nerves above the injury level to nerves below the injury

-next step :
- Source of info: – post by dr Young. May 2006

6) ACUTE AND CHRONIC SCI - Neuraxo Biotec – Cordaneurin [acute SCI- 2008] ChordaChron [chronic
   SCI- ???]

Update August 15 , 2006 :
Status To be checked
2 Trials :
- on Acute SCI : Cordaneurin :Trials should take place in 2008 ?
- on Chronic SCI : Chordachron : Trials will take place later [than 2008] ?
-Next step:
-Source of info: Carecure -

Update March 2006:
-Status: Neuraxo Biopharmaceuticals, a German biopharmaceutical company stands for pioneering the therapy of
acute and chronic Spinal Cord Injuries with its proprietary technology platform: the Regeneration Promoting
Treatment (RPT). As a first clinical application of the RPT Neuraxo is focusing on the clinical development of
Cordaneurin® - a drug for the treatment of acute Spinal Cord Injuries which received Orphan Drug Status in 2004.
In pre-clinical studies Cordaneurin® has already demonstrated its high efficacy in extensive recovery of sensory and
motor function. Cordaneurin® will enter clinical trials in the turn of 2005 / 2006. As a second application Neuraxo
will take up the challenge to develop a therapy also for chronic injured patients. This cure called CordaChronTM will
include additional components to Cordaneurin® such as the patent protected nerve growth stimulating factor, the
chemokine SDF-1gamma. First clinical trials with CordaChronTM are expected in 2008. Web site :
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-Source of info:March 2006 :
For more info, see Alarme [French and English] :,20.0.html

7)     Chronic SCI - The Neurosurgery Clinic (W. Jarmundowicz), Wroclaw, Poland - human OEG. 2006-
2007-2008) – starting Sept 2006

Update August 26, 2006:
- status [Aug 26. 2006] : First patient would receive treatment [clinical trial] in September 2006. Source is Polish
paper and Polish patient
- contact: Prof. Wlodzimierz Jarmundowicz M.D., Ph. D.
Department of Neurosurgery
Wroclaw Medical University
ul.Traugutta 118, 50-420 Wroclaw
tel. (+48 71)7890258, (+48 71)3430111 , fax (+48 71)3436747
Web site :
- source of info: carecure

Update December 2005:

Last November , they started preparation for the clinical trails in order to determine safety and efficiency of OEG
transplantation in patients with complete spinal cord injury. At the present time, they are in a process of recruiting
patients. Only patients whose cultured cells are "the best" for transplant will
qualify for surgery. The Polish team plans on to transplant OEGs in 12 patients in the next three years [2006-2007-
Source of info : carecure members.
More info, Alarme :,181.msg692.html#msg692

8) Acute SCI [1 to 6 months] Manipal Hospital, India, Bengalore, Bone marrow ASC- trial ongoing

Update August 2006:
- Status [May 2006]= “trial are ongoing. A few more patients are being recruited. Recruitment within India for
logistic reason”.
- Next steps : results should be known by end 2006
- Contact: Dr Satisch Totey- Ph.D - Director, Stem Cell Research Center, 080-25024600\
- Source of info: Dr Satish Totey.

Update : March 2006
- Status: The purpose of the study is to determine whether bone marrow derived mesenchymal stem cells are safe
and possibly effective in the treatment of spinal cord injury.
Study type : interventional
Study design : treatment, non –randomized, open label , uncontrolled, single group assignment, safety/efficacy
-Source of info :

9)    ACUTE and CHRONIC SCI – OFS –[Oscillating Field Simulator] - Cyberkinetics’ Andara – Dr
Borgens– USA-Indianapolis – [Acute:Trials ongoing] . Trials planned [chronic: 2007-2008]

Update 22 August 2006:
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-status: - Acute SCI : Trial/recruitment is ongoing for acute sci patients [less than 18 days after trauma], in
Indianapolis. Trial in 2007.

”There was a pilot device trial in 2005. “All 10 trial participants implanted with the OFS showed some
improvement in sensation at six months and the nine patients who remained in the trial also showed improvement
one year post surgery, although the degree of improvement varied by patient” {…} The Food and Drug
Administration has approved a second clinical trial involving 10 additional patients with severe spinal cord injuries.
It is expected to begin at the IU Medical Center in early 2005. This trial will again explore the efficacy of the OFS
device and could lead to a larger randomized trial for spinal cord injury patients.”

- next step: Chronic SCI : OFS PLUS System – Repair Chronic Nerve Damage – Projected Phase I, 2007-2008
    [source of info :]

-contact :
Scott A. Shapiro, M.D.
Office: (317) 630-7625
Fax: (317) 630-8721
Office Address:
Indiana University Medical Center
Wishard Memorial Hospital
Room 323 E. Outpatient Building
1001 West 10th St., Indianapolis, IN 46202

- Source of info:
    6042500566 9&newsLang=en

And Alarme [English and French],284.from13456.html#new

PHASE 1 trial – ongoing?

Update August 2006:
-Status : „Dr Prockop says that along with 5 other investigating centers they have had very encouraging results to
date with rats, and a center in China has had the same results with monkeys. [...]
The Phase I (Toxicity) Trial will be for Acutes only with contused thoracic injuries - six patients in total.
-next step : ???
-Contact : Dr Prockop Just
-Source : Carecure member‟s information

        Prasat Neurological institute
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Update August 15, 2006
Status : Recruitment has started.
Next step:
Contact: -Prof Ahnond Bunyaratvej- BANKKOK- Prasat Neurological institute
Source of info : carecure. and
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Update August 2006:
-Status: [extract dated April 2006]- Spinal Cord Society clinical director Dr Jim Faed said when approached work
was progressing well on preparing adult mesenchymal stem cells in their Dunedin lab for use in a clinical trial
Prof Gillett said he hoped to have a proposal for ethical approval around clinical trials ready to go within months.


Noela Vallis
428 Hinuera Rd
RD 2
Matamata - New-Zealand
Phone: 64 7 888 1728
Fax: 64 7 888 1776
E-mail :


-Source: Source :,04,19,4,00400 and Alarme [French and English],14.0.html

    13) Acute SCI - Embryonic stem-cell transplants – Keirstad and Geron. FDA approval pending- 2007 ?

Update August 2006:
-Status: EXTRACT FROM Geron website, Aug. 2006 : []
“After completion of preclinical animal toxicology and efficacy studies, we plan to prepare and file an
Investigational New Drug (IND) application to begin human clinical trials in 2007 for oligodendrocytes derived
from human embryonic stem cells to potentially treat acute spinal cord injuries. Eligibility criteria will be
determined when the sites have been selected”.

-Next step:
-Source of info: and

Update March 28, 2006 :
University of California, Irvine. This is a phase 1 trial that has been announced by Geron. They have initiated
arrangements with Cambrex to produce the cells, see [ ] and
have applied for permission to the FDA for the trial.

“The clinical trial that Keirstead hopes to conduct will take place next year [ie 2007] and would be in collaboration
with Geron, the leading biotechnology company in the field. The trial would be only for people with newly injured
spinal cords because his work shows they would be more likely to benefit. He is also working to apply that research
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to people with long-term paralysis like Suzanne Short. While Keirstead has been widely praised for his work, he has
also been criticized by some scientists for trying to rush his treatment into people.”

-Source February 2006 :

    14) Chronic SCI : Bone marrow stem cells + neuropeptides – Neuronax and C4H –France+NL- 2007 ?

Update August 2006:
Extract from May 2006 [translation from French]: « Neuronax has
just concluded an agreement for development and licence with the Dutch company Cells4health [...]
That agreement, which also associates the INSERM [French institute for medical research], concerns the NX
Peptide on which Neuronax has already completed promising pre-clinical studies. [...]
Within this partnership, the pre-clinical development of the peptides NX will be carried out by Neuronax , whereas
the clinical development and the commercialisation of the peptide will be ensured by Cells4Health »

-Next steps: ??
-Contact: Stéphane GOBRON - - Tel. (33) 4 73 17 83 88
-Source of information: Alarme‟s members -,471.0.html#lastPost

Update End 2005 :
Neuronax, a French bio-pharmaceutical company created in March 2003, focuses on discovering and developing
new therapeutic molecules aiming at the neuro-regeneration in case of traumas in the nervous system or
neurodegenerative illnesses. Preliminary results of test made on animal models of spinal cord injury seem to show a
big potential. Toxicological and pharmacological tests are now ongoing to enable a switch to human clinical trials.
For that purpose, a co-operation was started with the Dutch company Cells4health, NL

Pre-clinical development is planned to start mid 2006 and will be followed by the treatment of about 50 patients in
year 1 [assumed 2007], followed by more patients later-on, and by the potential approval and public launch of the
medication in year 5.

    15) The North American Clinical Trial Network (funded by Christopher Reeve) – planning to be
Update August 2006:
Latest status To be checked ???

Update : March 2006
Patients are now being recruited but no treatment has been specified. It is not clear yet what they are planning to
test. Human embryonic stem cells and human OECs might be included.

    16) Chronic SCI : OEG cells + FK506 – France-Feron-Dererchi – 2007-2008 ? to be confirmed

Update August 2006.
-Status: – status is not confirmed- to be checked
-Source of info:,121.0.html#lastPost

Update : end 2005 .
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-Status: Beginning of a pre-clinical study on OEG [olfactory ensheathing glial] cells transplant combined with an
immuno-modulator FK506. This study was initiated by dr Dererchi and Pr Feron [Universite de la Mediterranee –
Aix-Marseille II – France], in order to start, within 2-3 years [2007-2008 ?], in France, a clinical trial of phase II,
further to phase I trials which already took place in Australia [with participation of Pr Feron].
-source of info: Alarme [French only] :,121.0.html#lastPost

    17) Chronic SCI : OEG cells transplant – Australia – long term and ongoing . next phase not known

Update August 2006: nothing new ????
-Source of info : Alarme -,1452.0.html

Update : end 2005
There was a first publication concerning the results of the phase 1 of the Australian trial [OEG cells transplant],
which started in 2002-2003, and was led by Pr Alan Mackay-Sims from the Institute for Cell and Molecular
Therapy [Griffith University – Australia], showing that the patients did get no complication.
The cells were taken from 6 patients and were transplanted into their own injured spinal cord. Results regarding
possible progress will be published later. There should be a phase II but dates are not known.

    18) Chronic SCI : The Miami Project to Cure Paralysis U.S.A. – combination therapies- date > year 2011

Update August 15, 2006:

-status[August 08]: “Therefore, though early tests for safety with cells such as embryonic spinal
tissues and Schwann cells are either underway or imminent, it is unlikely that cell transplantation
therapies will be available for testing in humans within the next 4-5 years”.

-source of info: letter from Maria J. Amador, BSN, CRRN - Director of Education The Miami Project to
Cure Paralysis - at the University of Miami Miller School of

See carecure :

Research projects :
1. The Miami Project (M. Bunge), U.S.A. - Schwann cell transplants combined with cAMP and Rolipram.
2. The Miami Project to Cure Paralysis (J. Guest), U.S.A. - human OEG from nasal mucosa combined
with Rolipram

Update January 2005:
“In Chronic spinal cord, it may be necessary to implant tubular guidance scaffolds to help reconnect the spinal cord
on each end of the injury. A strategy that Dr. Martin Oudega examined is the use of freeze-dried porous guidance
scaffolds that have been impregnated with brain-derived neurotrophic factor (BDNF). BDNF is a growth factor
known to promote cell survival. In future studies, he plans to combine these scaffolds with cell transplantation
approaches such as Schwann cells or olfactory ensheathing cells. Whether studying strategies to block inhibitors or
ones that act directly on damaged nerves to promote regeneration, The Miami Project's research team is addressing
critical questions that will lead to cutting edge therapies for SCI.” See :

More info on Alarme[ French + English]:,49.0.html
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    19) SCI - University of Louisville (F. Roisen), U.S.A. - olfactory ensheathing cells. Not approved yet

Update August 2006:
Update March 2006.
“Meanwhile, Roisen and his team are moving forward with their research. They are forming a company called
Rhinocyte and soon will talk with the U.S. Food and Drug Administration, a first step toward clinical trials.”

Source- march 2006 :

    20) SCI - NTT Project (J. McDonald), Columbia - person's own DNA and embryonic stem cells.- 2007?
Update May 2006:
- Status :
Extract from the May 06 NTT Newsletter . “One of the goals is to develop and apply an effective transplantation
method for embryonic stem cells (ES) for repair of the human spinal cord. Briefly, we will combine new methods
for generating ES cells with less invasive approaches for transplantation in the spinal cord.”

NTT is financed by Kennedy-Krieger Institute and Johns Hopkins International Medicine but needs extra outside
funding to be able to complete the project in time [target is to complete de primate studies in 1.5years].

“Project requiring funding :
Project 1a: Identifying the ES cell tissue genetic factors critical to prevent rejection of transplanted cells. […]. A
proof of principle is required in primates.
Project 1b: Human ES cell transplantation in primates.”
- Source of info: May 06 NTT Newsletter.

Update March 28, 2006 :
“Primate studies are in the initial stages, McDonald said. They are based in Bogota, Colombia, and focus on
nervous system genetics and stem cells…. Embryonic stem cells offer the greatest hope because they can be
implanted with the DNA of the transplant recipient.(…)
McDonald believes proof-of-principle primate studies can be completed within a year. Human studies can begin
after that. Exactly when is unsure…
Conrad Dobler believes it could be a matter of months, not years. “

Source :
More info on carecure :

    21) SCI - Reliance Life – India, Mumbai – embryonic stem cell research – 2006-2007 ??

Update August 2006:
Reliance Life Sciences Pvt. Ltd.
Dhirubhai Ambani Life Sciences Centre,
R282 TTC Area of MIDC,
Thane-Belapur Road, Rabale,
Navi Mumbai 400 701, INDIA.
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Tel. : +91-22-3911 8000
Fax : +91-22-3911 8099

Update March 2006:
-status: ”Reliance Life Sciences (RLS), the pioneer of embryonic stem cell research in the country, is likely to
launch its first stem cell-based therapies for neuro-degenerated diseases, including Parkinson‟s and ocular diseases
and spinal cord injury soon.
 Considering the successful completion of the pre-clinical and clinical studies with due regulatory approval in
another six months to one year period, these novel therapies are likely to be launched in the country by the end of
next year [2007] , sources from the company said.” Web site :
-Source :
More info on Alarme [French and English]:,1780.0.html

     22) SCI – INDIA- MUMBAI – Dr Alok Sharma. Clinical trial in coming years ?
Update August 15, 2006:
- Status: check is ongoing [mail sent to Dr Sharma. August 06]
- Contact : Dr Alok Sharma
Professor & Head
Department of Neurosurgery
LTMG Hospital & LTM Medical College
Sion, Mumbai-400022, India
office: +91 22 4024713 - fax: +91 22 4076100;
-Source of info:

    23)    SCI - MAYO CLINIC – USA – DR Windebank – Biodegradable scaffold+stemcells
Update August 2006:
-status: “The project combines adult stem cell research being conducted at REMEDI with a tissue
engineering breakthrough pioneered at the Mayo Clinic. […]. Using a simple biodegradable „scaffold‟
which we have engineered at the Mayo Clinic and the adult stem cells, we have had some success in
terms of the peripheral nervous system and with trials on animals.[…] . The „scaffold‟ acts as the
bridge for the stem cells to make the reconnection. “
-contact: Dr Windebank
-source of info:,18350,en.html

    24) RESCUE – European project – Alain Privat – animal study to be transposed to human by 2008 ?

Update : february 2006
European project launched in February 2006, co-ordinated by Alain Privat, director of the Institut des
neurosciences de Montpellier [France]
Participating countries : Germany, England, Belgium, Spain, France, Czech Republic
Two different therapeutic approaches :
- the first one should allow to evaluate the effectiveness of human adult and embryonic stem-cell transplants to
quadriplegic animal models,
- the second one deals with the risk of tumor development and the long term effects of the stem cells transplants.
The evolution of the various stemcells of various origins [neural, bonemarrow, glial..] will be compared .
The final objective will be to transpose the conclusions of the studies regarding the stemcell transplantations to
humans by 2008.
Source of info : February 2006,
More info on Alarme [French only] :,1750.0.html

Description: Clinical Trial Application at Germany document sample