Printable
Document
What is
ProCord?
ProCord is the name that was chosen
by Proneuron for the autologous incubated macrophage procedure.
What is
the Phase II study?
The Phase II clinical trial is an
international, multi-center, randomized-controlled study performed
under the U.S. Food and Drug Administration's (FDA) regulations to
test the safety and efficacy of the procedure in patients with acute
complete spinal cord injuries. The official name of the study is
"A Phase II, Multicenter, Randomized-Controlled Study to Evaluate
the Safety and Efficacy of Autologous Incubated Macrophages for the
Treatment of Patients with Spinal Cord Injuries." ProCord
received FDA orphan drug designation status in September 2004.
Who can participate
in the clinical study?
Study enrollment for the Phase
II trial is open to 61 patients who meet eligibility criteria,
including but not limited to the following, age 16-65, with complete
spinal cord injury. Complete injury is defined as ASIA Grade A-
neither feeling nor movement below the point of injury. Neurological
level of injury: C-5 to T-11. The principal investigators in the
study sites are exclusively responsible for determining a patient's
eligibility for the trial on the basis of a study protocol that was
approved by the appropriate authorities.
NOTE: This is a
randomized-controlled clinical trial. This means that patients found
eligible for the study will be randomly assigned to either a
treatment or control group, two treatment patients for every one
control patient, on average. Control patients will not receive the
procedure. All control and treatment patients will receive standard
spinal cord injury rehabilitation and will receive follow-up testing
for one year. ProCord must be administered within 14 days of injury
to meet study criteria.
Who to
call about enrollment?
Patient, Immediate Family
of Patient and/or Physician inquiries:
24 hours a day Patient
Recruitment Center:
Please use the ONLINE REFERRAL FORM or one of the
following:
Email: clinical.trial@proneuron.com
Telephone: 1-866-539-0767 (U.S. toll free) or
1-506-652-3486
Fax: 1-866-214-7078
*Callers outside of the
U.S., please use standard international dialing codes
What does the
Patient Recruitment Call Center do?
The Patient
Recruitment Call Center collects limited preliminary data that
assists the investigators in the determination of eligibility to
participate in the study. Following this initial process, when
relevant, the patient will then be referred to a study site for
screening procedures relevant to study criteria.
Will
everyone enrolled receive the ProCord
procedure?
Patients will be randomly assigned to
treatment and control groups (at the treatment site), two treatment
patients for one control patient. The random assignment is not
reversible. Patients have a one in three chance of assignment to the
control group, which will receive standard care, but not the ProCord
procedure.
NOTE: There is NO placebo
procedure; there is NO mock surgery. All patients, including those
in the control group, will receive standard spinal cord injury
rehabilitation and will receive follow-up testing for one year.
Is there a specific
window of opportunity?
Yes. ProCord must be
administered within 14 days of the injury to meet study criteria.
Investigators need to be notified of a potential candidate within a
few days of their spinal cord injury in order to give ample time for
patients to enroll and participate in the 14-day window of the
clinical trial.
What
does follow-up include?
All patients (including those
in the control group) will receive standard spinal cord injury
rehabilitation and will be followed for one year. The follow-up will
include general and neurological examinations and MRIs. The primary
endpoint to assess efficacy is improvement in ASIA classification to
grade ASIA B or better, essentially some degree of feeling and/or
control of muscles.
What are
macrophages?
Following tissue injury, a type of white
blood cell, called a macrophage, quickly starts to remove cell
debris. These macrophages then start to secrete growth factors that
promote a controlled inflammatory reaction to initiate the wound
healing process. While this process occurs effectively in most
tissues including peripheral nerves, it does not occur effectively
in the central nervous system (CNS). Discoveries led by Prof. Michal
Schwartz of the Weizmann Institute of Science have shown in
pre-clinical studies that specially treated macrophages, however,
promoted recovery from spinal cord injury (SCI). Based on these
findings, Proneuron is now evaluating the safety and efficacy of
ProCord, currently an experimental procedure for patients with acute
spinal cord injury.
What is an
autologous incubated macrophage?
Autologous incubated
macrophages are macrophages, isolated from the patient's own blood,
activated through a proprietary process and then injected directly
into the patient's injured spinal cord at the site of the lesion.
What is the procedure
for ProCord itself?
The idea is to draw blood from
the patient, collect a type of white blood cell called a macrophage,
"treat and educate" them and then, in a surgical procedure, inject
them into the spinal cord for the purpose of stimulating a repair
process. Specifically, blood and skin taken from the arm of the
patient is processed in a Proneuron Cell Center for approximately
one and a half days. The resulting activated macrophages are
implanted during a surgical procedure.
Who
discovered ProCord?
Proneuron Biotechnologies (www.proneuron.com) is developing
ProCord therapy based on the research of Professor Michal Schwartz
of the Weizmann Institute of Science in Rehovot, Israel.
Has ProCord
been clinically tested in humans before?
There were
three previous studies conducted at two different medical centers
that enrolled 16 patients coming from the US, Mexico, Israel,
Holland, Belgium, and Poland.
What were
the results of the Phase I trial of ProCord?
Final
results of the Phase I study have yet to be published, as there
remain several patients still within the one-year follow up.
However, as of September 2004, four of 16 patients from the early
studies (all initially diagnosed as suffering from a complete spinal
cord injury) became incomplete following the administration of
ProCord, obtaining movement and/or feeling not only below their
injury but also into their lower extremities.
How is the Phase II
study going thus far?
In accordance with FDA
guidelines and to insure the integrity of the trial, we are unable
to disclose any information pertaining to the status of the Phase II
study at this time.
What
hospitals are participating in the study of this experimental
treatment?
In December 2003, Craig Hospital in
Denver, Colorado became the first hospital in the U.S. to
participate in the trial. In 2004, three other sites in the U.S.
began enrolling as treatment sites. These include: The Mount
Sinai Medical Center in New York, New York; Kessler Institute
for Rehabilitation in West Orange, New Jersey in cooperation
with The University Hospital in Newark, New Jersey; and
Shriners Hospitals for Children in Philadelphia,
Pennsylvania. Shepherd Center in Atlanta, Georgia,
anticipated to become a treatment site in early 2005, is already
taking an active role in the study as a referral and rehabilitation
center. Additional protocol follow-up sites include:
Rehabilitation Institute of Michigan (RIM) in cooperation
with Detroit Receiving Hospital in Michigan and Santa
Clara Valley Medical Center in California. The Chaim Sheba
Medical Center in Israel was the first site to enroll patients
in the international, Phase II ProCord study beginning in September
2003.
Who oversees the
safety of the clinical trial?
The FDA has approved
the conduct of the international, multi-center,
randomized-controlled, Phase II study of ProCord and shall review
all information collected. An independent safety committee is in
place for reviews throughout.
Is
there anyone I can speak with who is enrolled in the Phase II
Clinical Trial?
No, sorry. The identity of those
enrolled in the study is strictly confidential.
How much does it cost to
participate?
For patients accepted to the study,
there is no cost associated with the actual ProCord procedure. The
patient's insurance typically covers the standard spinal cord injury
rehabilitation program following enrollment in the study.
Who is
Proneuron?
Proneuron Biotechnologies Inc., a Delaware
company, is a privately held biopharmaceutical company developing
products for the medical treatment of spinal cord injuries and other
disorders of the central nervous system. Proneuron's products are
based on proprietary technology for modulating the interaction
between the nervous and immune systems. The Company's products are
currently being evaluated in several clinical studies located in the
U.S., Belgium and Israel. These include: an independently managed,
international, multi-center, randomized-controlled Phase II trial of
ProCord, autologous incubated macrophages, an experimental procedure
for spinal cord injuries and a Phase II program of Cop-1 for the
treatment of Huntington's disease (HD), glaucoma and other
neurodegenerative diseases. The latter is being managed by Teva as
part of the Proneuron's strategic collaboration for development and
commercialization of Cop-1 for various neurodegenerative
indications. The Company is also developing PN277 for the treatment
of additional neurodegenerative diseases.
Printable
Document
