2nd Phase 1 for Proneuron's Activated Macrophages

[George78]

A 2nd Phase 1 of Proneuron's Macrophages Activated Therapy is now running in Brussels - Hopital Erasme - Professor Brotchi - Phone: + 32(0) 555-37-68 or +32(0) 555-37-51 Fax +32(0) 555-37-55 - E-mail Sylvie Marecaux: smarecau@ulb.ac.be - Neurosurgery Service - Route de Lennik 808 - 1070 Brussels - Belgium.

The head of the project is Dr. Florence Lefranc at Erasme. Inclusion criteria for the second Phase 1 are the same for the first phase 1, except that patients must be treated before 3 weeks after the injury.

A first patient has already been involved in the trial. The surgery went well. It's too early to state any improvements.

George du Chesne
Paratetra asbl
http://www.paratetra.net

[George78]

Two Patients have been involved in Brussel's activated macrophages trial. First one on november 23th 2001, second one on january 16 2002. It's too early to talk about recoveries... I will let you know as soon as I know.
George
http://www.paratetra.net

[jb]

is there any place on that website where it's translated in english? also when you click on the british flag, it sends you back to the can cure webpage.

[George78]

Nearly the whole of our web site is translations from carecure forum. Paratetra.net is a small carecure in french. My association is closely working with Prof. Brotchi's unit right here in Brussels. If you have any questions regarding both macrophages activated surgeries of Dr. Lefranc and stem cells project of Prof. Pandolfo, please let me know I will ask Prof. Brotchi. But be sure you aren't missing any informations from Paratetra.net...
George

[Wise Young]

http://www.centerwatch.com/patient/studies/stu32468.html

Trial Information

Summary: A study for patients with diagnosed complete spinal cord injury between C6 and T11.

Suitable patients will be transported to Belgium to undergo the experimental therapy. The treatment consists of taking blood and tissue from the patient, isolation and activation of macrophages in Proneuron's special facility, then surgical implantation administration of the autologous cells back to the patient by one of the participating neurosurgeons.

The patient will be required to remain in Belgium for approximately 3 months for follow-up evaluation and rehabilitation. Proneuron is willing to cover the costs for transporting the patient, and 3 months of medical costs including treatment, hospitalization and rehabilitation.

Patients are expected to return home after 3 months, but will be periodically assessed for at least a further 9 months by Proneuron-appointed staff. Proneuron will cover the costs of the assessments.

Inclusion criteria:

* Age 16-65, male or female
* Definitively diagnosed complete spinal cord injury at any level from C6 to T11 inclusive
* Lesion confined to one spinal segment and location confirmed by MRI
* Injury due to blunt, non-penetrating trauma
* Can be treated within 21 days of injury
Exclusion criteria:

* Coma or other severe neurological injuries or diseases
* Unstable multiple trauma
* Severe or infectious concurrent medical disease
* Concurrent pregnancy
The Principal Investigator for this study is Prof. Jacques Brotchi, Head of Neurosurgery at the Erasme Hospital, Brussels


Contact:
Valentin Fulga, M.D.
Proneuron Biotechnologies
Located in:
Brussels, Belgium,
Telephone: +972 8 9409550
Fax: +972 8 9409560
Email: clinical.trial@proneuron.com

[KLD]

Heard Dr. Fulga speak at SCI conference in San Diego on Monday and he stated that they expect FDA approval for Phase II Proneuron study in the USA this year. Rumor at the conference was that Craig will be the clinical site for the study....

[Chris Chappell]

You're right about Craig.

Onward and Upward!

[jb]

do you know if those doctors plan to use chronics in the near future. or will this be strictly for acutes? what if someone volunteered?

[George78]

jb, I don't know if they plan to use chronics, but what I know is that a Cellular Center abled to treat activated macrophages is very expensive. The second phase 1 in Brussels has a window range of 3 weeks, the one of Israel 2. They increased 50% the window range. I think what we need are official results from Isra�l. If the procedure is safe I hope Proneuron will go chronicals.
George

[George78]

Four patients have been involved in Proneuron surgeries: 2 quads and 2 paras. After 6 months, no sides effects to report.
1st patient: 6 months post surgery - no changes
2nd patient: went back to NY - some sensitive recoveries
3rd patient: complications not linked to the surgery
4th patient: they've just done the surgery.
George

[Chris Chappell]

Thank you for the update.

You probably already know that Craig Hospital, Denver CO will be the first U.S. facility offering this treatment. Estimated date is Spring 2003.

Onward and Upward!