Adult Stem Cells Implanted By Catheter Rejuvinate Heart After Heart
Attack
ScienceDaily (Oct. 11, 2007) — A team of cardiologists at the
University Hospital of Navarre, in collaboration with the Area of
Cell Therapy at the same centre, and with the Gregorio Marañón
Hospital in Madrid, have carried out clinical trials (phase II) on 50
patients in order to test the efficacy of adult stem sell transplants
(in this case, myoblasts), in the heart of persons who have suffered
a myocardial attack. The great novelty of this work compared to
others of a similar nature is the implantation of stem cells using a
catheter and not through open surgery, used to date.
The current study is based on previous research carried out on
experimental animals. This is a study approved by the Spanish
Medication Agency, an official body certifying that the research
complies with the legal, ethical and safety requisites of the
patient.
The patients that are or will be involved in this trial are those who
have suffered myocardial arrest and have ventricular dysfunction.
Before subjecting them to the stem cell transplant, a series of tests
are carried out with them such as ecocardiograms, magnetic resonance,
analysis and the evaluation of spontaneous arrhythmia using Holter-
ECG.
The technique begins with the extraction of myoblast cells, by means
of a biopsy of muscular tissue from the leg of the patient, a
procedure carried out under local anaesthetic. From the tissue
fragment obtained, the researchers isolate the adult muscle stem
cells. These cellular units must be cultured for a month in order to
obtain sufficient numbers of cells to carry out the transplant.
The culture of the cells is undertaken in the GMP (Good Manufacturing
Practice) laboratory of the University Hospital of Navarra, a
technique that is based on using the patient's own serum, unlike the
cultures undertaken in other studies that use animal-origin serum –
and thus reduces the risk of adverse reactions. "In this way,
possible infections, allergies or immunological reactions are
avoided, given that foreign proteins are not introduced", according
to doctor Juan José Gavira, cardiologist at the University Hospital
of Navarra. The serum is obtained by carrying out a plasmapheresis, a
technique which obtains the plasma in which the myoblasts are
cultured.
After the month required for the growth of the cell population, the
cells obtained are injected into the heart of the patient by
catheterism, using a special injection catheter. The cells are
implanted in and around the damaged areas of cardiac muscle.
One of the requirements included in the clinical trials that patients
have to meet is that no other invasive therapy should simultaneously
accompany this trial. In this way, pointed out Dr Gavira, "the
results obtained are much purer, given that no other treatment
interferes with them". Having obtained the adult stem cells, a sample
thereof is analysed in the Microbiology Laboratory in order to
discard the existence of infections and to certify its perfect state.
The implant of stem cells
In order to implant myoblasts it is necessary to generate an
anatomical reproduction of the left ventricle, which is the zone to
be treated. This virtual reproduction is carried out by means of a
navigation system known as non-fluoroscopic electroanatomical
mapping. This technique manages to reconstruct the left ventricle in
a three-dimensional form, a system that enables the location and
analyses of low-voltage areas.
"It is these zones without electrical activity that anatomically
correspond to the heart attack. With this generation of the
ventricle, obtained thanks to the navigation system, we identify the
zone affected by the myocardial attack", explains Doctor Ignacio
García Bolao, specialist in the Cardiology Department at the
University Hospital.
It is in this zone that the stem cells have to be injected. The
procedure is undertaken by introducing a catheter made up of a very
fine needle retractable at its end. The catheterism is carried out,
as is habitual, through the femoral artery until the exact area of
the heart affected is reached. Once there, between 15 and 20
injections of myoblasts are effected. The procedure is undertaken
using local anaesthetic, with the patient being conscious, and lasts
three or four hours. To date 14 patients have undergone the trials,
all with satisfactory results.
The technique is part of research trials the Phase II goal of which
is to see if this new treatment is effective and to improve on the
cardiac function of patients who have suffered a heart attack.
Adapted from materials provided by Basque Research.
http://www.scienced
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StemCells subscribers may also be interested in these sites:
Children's Neurobiological Solutions
http://www.CNSfoundation.org/
Cord Blood Registry
http://www.CordBlood.com/at.cgi?a=150123
The CNS Healing Group
http://groups.yahoo.com/group/CNS_Healing
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