The long answer gets very technical so I will give you a nutshell answer.  GVHD comes into plays when you are working with cells that have markers on the outside of their little cell bodies.  These are cells such as red blood cells or more mature stem cells.  The Umbilical Cord stem cells used by China have undergone intensive magnetic washing to remove all red blood cells and white cells thus all that is left in the end is pure immature stem cells.  Since they are in such a “young” stage relative to the age process of a stem cell they have no markers.  Because of this the body see’s them as “self” therefore the body does not reject them.

This is also why blood typing and matching is not needed.

Love Kirshner

-----Original Message-----
From: stemcellsafety@yahoogroups.com [mailto:stemcellsafety@yahoogroups.com] On Behalf Of kirshvaden
Sent: Friday, September 22, 2006 12:16 PM
To: stemcellsafety@yahoogroups.com
Subject: [stemcellsafety] Stem Cell study currently recruiting

Long-Term Evaluation and Follow-Up Care of Patients Treated With
Stem Cell Transplants

This study is currently recruiting patients.
Verified by National Institutes of Health Clinical Center (CC) March
2006

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Institutes of Health Clinical
Center (CC)
ClinicalTrials.gov Identifier: NCT00106925


Purpose

This study will provide follow-up evaluation and care of patients
who have undergone allogeneic (donor) stem cell transplantation at
the NIH Clinical Center. Patients are monitored for their response
to treatment, disease relapse, and later-occurring effects of the
transplant.

Patients between 10 and 80 years of age who received a donor stem
cell transplant at the NIH Clinical Center under an NHLBI protocol
may be eligible for this study. Candidates must have had their first
transplant at least 3 years before entering the current study.

Participants are generally seen in the clinic every 12 months for
some or all of the following procedures:

Periodic physical examinations, eye examinations, and blood and
urine tests.
Bone marrow aspiration and biopsy: A sample of bone marrow is
obtained for microscopic examination. The patient is given local
anesthesia or conscious sedation. An area of the hipbone is numbed,
a thin needle is inserted through the skin into the bone, and a
small amount of marrow is withdrawn.
Tissue biopsy: A small piece of tissue or tumor is obtained for
microscopic examination. Depending on the site of the biopsy, the
tissue may be removed using a cookie cutter-like "punch" instrument,
a needle, or a knife. The area is numbed and the tissue is removed
with the appropriate tool.
Imaging tests to visualize organs, tissues, and cellular activity in
specific tissues. For these tests, the patient lies on a table that
slides into the scanner. They may include the following:

Nuclear scans use a sensitive camera to track a small amount of
radioactive material (radioisotope) that is given to the patient by
mouth or through a vein. The scan may show abnormal areas of tissue
in the bones, liver, spleen, kidney, brain, thyroid, or spine.
Magnetic resonance imaging (MRI) uses a magnetic field and radio
waves to examine small sections of body organs and tissues.
Computerized tomography (CT) uses x-rays and can be done from
different angles to provide a 3-dimensional view of tissues and
organs.
Positron emission tomography (PET) uses a fluid with a radioisotope
attached to it to show cellular activity in specific tissues. The
fluid is given through a vein and travels to the cells that are most
active (like cancer cells), showing if there is an actively growing
tumor.
Pulmonary (lung) function tests: The patient breathes into a machine
that measures the volume of air the person can move into and out of
the lungs.
Heart function tests may include the following:

Electrocardiogram (EKG) evaluates the electrical activity of the
heart. Electrodes placed on the chest transmit information from the
heart to a machine.
Echocardiogram (Echo) is an ultrasound test that uses sound waves to
create an image of the heart and examine the function of the heart
chambers and valves.
Multiple gated acquisition scan (MUGA) is a nuclear medicine test
that uses a small amount of radioactive chemical injected into a
vein. A special scanner creates an image of the heart for examining
the beating motion of the muscle.
Disease relapse or progression, or transplant-related problems may
be treated with standard medical, radiation, or surgical therapy, or
patients may be offered experimental therapy.

Condition
Stem Cell Transplantation
Transplantation, Homologous
Allogenic Stem Cell Transplant Recipient


MedlinePlus consumer health information

Study Type: Observational
Study Design: Natural History

Official Title: Long-Term Evaluation and Follow Up Care of Patients
Treated With Allogeneic Stem Cell Transplants

Further study details as provided by National Institutes of Health
Clinical Center (CC):
Study start: March 2005
Last follow-up: March 2006; Data entry closure: March 2006

While patients surviving more than three years from SCT have a high
probability of being cured of their underlying disease, they are
still at risk from several categories of complications which could
remain lifelong risks including late recurrence (or continued
persistence) of original disease, late effects from transplant
related GVHD, immune dysfunction, or consequences from the
chemotherapy and/or radiation given during transplant conditioning.

Since these complications are iatrogenic, the long term follow-up of
SCT patients is the ethical responsibility of the transplant team.
In addition, collecting data on late occurring complications allows
for prospective evaluation of the long term consequences of
surviving a particular transplant treatment approach (i.e. total
body irradiation versus chemotherapy conditioning, T cell depleted
versus T cell replete transplants).

This protocol is designed to allow for long term evaluation, data
collection, and when needed standard medical care of patients (and
when appropriate their stem cell donor) who have received allogeneic
stem cell transplantation in NHLBI protocols. This may include
patients with bone marrow failure states, cytopenias,
hemoglobinopathies, metastatic solid tumors, or hematologic
malignancies.

No investigational treatments will be administered on this protocol.
Participation will not constitute a promise of long-term medical
care at the NIH, nor will it provide for the evaluation and
treatment of any non-transplant related medical problems. This
protocol will provide access to NIH hematologists experienced in the
care of post transplant patients who can help transplant patients
and their local physician manage post transplant complications. In
return, data collected from subjects will provide NIH researchers
valuable information for the purposes of better understanding the
long term consequences of stem cell transplantation and identifying
areas in need of future research.

Eligibility

Ages Eligible for Study: 7 Years - 80 Years, Genders Eligible
for Study: Both
Criteria
INCLUSION CRITERIA - TRANSPLANT RECIPIENTS
Patients surviving three years or more from date of first stem cell
transplant who have been treated:

-With an experimental allogeneic stem cell transplant on a NHLBI HB
protocol

Or

-With a standard of care allogeneic stem cell transplant on the
NHLBI standard of care protocol

Or

-As a special exemption to the above protocols

Age greater than or equal to 10 years old and age less than or equal
to 80

For adults: Ability to comprehend the investigational nature of the
study and provide informed consent. For minors: Written informed
consent from one parent or guardian and informed assent: The process
will be explained to the minor on a level of complexity appropriate
for their age and ability to comprehend.

EXCLUSION CRITERIA - STEM CELL TRANSPLANT RECIPIENTS

None, all patients meeting the inclusion criteria will be eligible

INCLUSION CRITERIA - DONOR

If appropriate clinical management of the recipient would indicate
the need for additional stem cell collection, a donor may also be
accrued to this protocol providing they meet the following criteria:

HLA 5/6 or 6/6 matched family donor
Weight greater than or equal to 18 kg
Age greater than or equal to 2 or less than or equal to 80 years old
For adults: Ability to comprehend the investigational nature of the
study and provide informed consent. For minors: Written informed
consent from one parent or guardian and informed assent: The process
will be explained to t he minor on a level of complexity appropriate
for their age and ability to comprehend.
EXCLUSION CRITERIA - DONOR (ANY OF THE FOLLOWING)

Pregnant or lactating
Donor unfit to receive filgrastim and undergo apheresis.
(Uncontrolled hypertension, history of congestive heart failure or
unstable angina, thrombocytopenia)
HIV positive. Donors who are positive for HBV, HCV or HTLV-1 may be
used if the risk-benefit ratio is considered acceptable by the
patient and investigator
Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier
NCT00106925

Patient Recruitment and Public Liaison Office (800) 411-1222
prpl@....nih.gov
TTY 1-866-411-1010

Maryland
National Heart, Lung and Blood Institute (NHLBI), Bethesda,
Maryland, 20892, United States; Recruiting
More Information

NIH Clinical Center Detailed Web Page

Publications

Maraninchi D, Gluckman E, Blaise D, Guyotat D, Rio B, Pico JL,
Leblond V, Michallet M, Dreyfus F, Ifrah N, et al. Impact of T-cell
depletion on outcome of allogeneic bone-marrow transplantation for
standard-risk leukaemias. Lancet. 1987 Jul 25;2(8552):175-8.

Study ID Numbers: 050130; 05-H-0130
Last Updated: August 29, 2006
Record first received: June 19, 2006
ClinicalTrials.gov Identifier: NCT00106925
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-09-21