By Cherie C. Binns RN BS MSCN
July 14, 2014
I
received a color brochure in my email from Stem Genex® asking me to locate
subjects with worsening Multiple Sclerosis to participate in their study listed
in www.clinicaltrials.gov under Multiple
Sclerosis. I am familiar with this
company as I researched it for some folks 4 years ago and again each of the
succeeding years.
received a color brochure in my email from Stem Genex® asking me to locate
subjects with worsening Multiple Sclerosis to participate in their study listed
in www.clinicaltrials.gov under Multiple
Sclerosis. I am familiar with this
company as I researched it for some folks 4 years ago and again each of the
succeeding years.
There is no company funding for this and it is entirely patient funded to the tune of
$12,000-$14,000 per treatment with at least two treatments recommended 6 months
to a year apart. There are only two
locations in the United States that do this procedure and staff is sent to
Spain to be trained.
$12,000-$14,000 per treatment with at least two treatments recommended 6 months
to a year apart. There are only two
locations in the United States that do this procedure and staff is sent to
Spain to be trained.
The
procedure involves you flying to the location of the therapy, staying in a
motel overnight, coming to the clinic the following morning to have blood drawn
from your arm and a two incision (potentially more if you are very thin) “mini
liposuction” on your abdomen. The cells
then from the abdomen are spun out, mixed with your blood and given back to you
in a saline IV over the course of a couple of hours. You spend another night in the motel and if
there are no problems, may fly home in the morning. Airfare and motel is your expense. The “kit” to do this is available online for
$2500 and costs you, at the clinic, $12,000.
procedure involves you flying to the location of the therapy, staying in a
motel overnight, coming to the clinic the following morning to have blood drawn
from your arm and a two incision (potentially more if you are very thin) “mini
liposuction” on your abdomen. The cells
then from the abdomen are spun out, mixed with your blood and given back to you
in a saline IV over the course of a couple of hours. You spend another night in the motel and if
there are no problems, may fly home in the morning. Airfare and motel is your expense. The “kit” to do this is available online for
$2500 and costs you, at the clinic, $12,000.
I
know of three people who paid this money, had the procedure done and are worse
a year later than they were when they went for the procedure. There are, of course all sorts of people the
company will put on the phone with you to tell you they had it done, had not
walked in years and are doing everything unaided now.
know of three people who paid this money, had the procedure done and are worse
a year later than they were when they went for the procedure. There are, of course all sorts of people the
company will put on the phone with you to tell you they had it done, had not
walked in years and are doing everything unaided now.
This
got onto www.clinicaltrials.gov because it is a “study” and,
as such, qualifies for free advertising in this venue. They are using it to reach as many desperate
People with Multiple Sclerosis as they can to sell this treatment to and will
then agree to follow up and provide the clinicaltrials.gov people with study
results.
got onto www.clinicaltrials.gov because it is a “study” and,
as such, qualifies for free advertising in this venue. They are using it to reach as many desperate
People with Multiple Sclerosis as they can to sell this treatment to and will
then agree to follow up and provide the clinicaltrials.gov people with study
results.
This
procedure may have benefits BUT a legitimate clinical trial will pay for all
treatment costs and most will compensate for time and travel See next page for listing of trial ,
inclusion criteria, contact person, etc.
BEWARE!
procedure may have benefits BUT a legitimate clinical trial will pay for all
treatment costs and most will compensate for time and travel See next page for listing of trial ,
inclusion criteria, contact person, etc.
BEWARE!
Written for
MS Views and News at Request of Stuart Schlossman 7/14/14
MS Views and News at Request of Stuart Schlossman 7/14/14
Recruiting
|
Condition: Multiple Sclerosis
|
|
Intervention:
|
Change from Baseline on the Multiple Sclerosis Quality of
Life Inventory (MSQLI) at 12 months [ Time Frame: Baseline, 12 months ] [
Designated as safety issue: No ]Primary Outcome Measures:
Estimated Enrollment: 100
Study Start Date: May 2014
Estimated Primary Completion Date: May 2017 (Final data collection date
for primary outcome measure)
for primary outcome measure)
Eligibility
Ages Eligible for Study: 18
Years to 65 Years
Years to 65 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability
Sample
Sample
Study Population
Community sample
Criteria
Inclusion Criteria:
Subjects scheduled for a stem cell/SVF
treatment
treatment
Subjects diagnosed with some form of
multiple sclerosis
multiple sclerosis
Subjects between the ages of 18 and 65
Subjects willing and able to sign
informed consent
informed consent
Subjects willing and able to perform
follow up interviews and surveys
follow up interviews and surveys
Exclusion Criteria:
Subjects for whom baseline data is not
available
available
Subjects with additional major health
diagnoses
diagnoses
Subjects that are pregnant or
breastfeeding
breastfeeding
Contacts and
Locations
Locations
Choosing to participate in a study is an important personal
decision. Talk with your doctor and family members or friends about deciding to
join a study. To learn more about this study, you or your doctor may contact
the study research staff using the Contacts provided below. For general
information, see Learn About Clinical Studies.
decision. Talk with your doctor and family members or friends about deciding to
join a study. To learn more about this study, you or your doctor may contact
the study research staff using the Contacts provided below. For general
information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov
identifier: NCT02157064
identifier: NCT02157064
Contacts
Contact: Dawn Thorpe 800-609-7795
Locations
United States, California
StemGenex Recruiting
La Jolla, California, United States,
92037
92037
Contact: Dawn Thorpe 800-609-7795
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