Indications / Contraindications

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During the last 90+ years physicians have utilized fetal precursor cell transplantation as treatment of many diseases, whenever they recognized that the patient needs a direct stimulation of regeneration, i.e. repair of the damaged cells or tissues of various organs.

Certain diseases or groups of diseases have been treated by fetal precursor cell transplantation more than the others, and so more clinical experience has been accumulated, or more scientific papers written. There are very many publications about the neurotransplantation for Parkinson’s disease, although only a few patients have been so treated and the reported results have been outright poor. Very few reports have been written about the treatment of immune system diseases by fetal precirsor cell transplantation until very recently, and too few patients treated, although there is strong reason to believe that fetal precursor cell transplantation is the best immunostimulant available to the medicine today, capable to restore even the immune function in the pre-terminal AIDS patients. Very few reports have been written about the treatment of aging disease, although millions of patients have been treated for such indication.

The list of indications that follows is rather arbitrary, as well as comments on the patient selection. Both the physician and the patient must realize that scar tissue cannot be ‘turned back’ to become a functioning original healthy tissue again, and fetal precursor cell transplantation cannot accomplish it either.

Diabetes Mellitus: Juvenile and adult patients should be accepted for treatment by fetal precursor cell transplantation only when they already developed complications of diabetes, such as

a/ Retinopathy: all patients in the pre-proliferative stage should be accepted, while those in the proliferative stage may be refused, it all depends on the details of the clinical situation, and the patient’s determination, but it is really pointless to treat patients that are blind already.

b/ Nephropathy: only patients in the pre-uremic stage should be accepted, i.e. patients with various degrees of proteinuria, micro- or macro-albuminuria, but with acceptable creatinine clerance.

c/ Polyneuropathy: all patients are accepted.

d/ Peripheral arterial disease: no patients with gangrene of their lower extremity are accepted, while all patients in pre-gangrenous stage must be accepted.

(Patient selection for treatment of diabetic complications is covered extensively in the chapter on ‘Therapeutic goal of fetal precursor cell transplantation’).

Children and juveniles: all patients are accepted, preferably in the acute stage, i.e. as soon after the onset of the disease as possible, as well as all patients with ‘brittle diabetes’.

Pregnant women with a history of diabetic fetopathy, or women with infertility due to diabetes mellitus: all patients are accepted, but they must be treated before the pregnancy commences, or during the period between 12th to 16th week of pregnancy.

Insulin-independent Diabetes Mellitus (type 2): Obese patients with type 2 diabetes mellitus should be refused, and that presents a dilemma for the treating physician when such patient develops a diabetic complication and it is progressing fast. Obese patients with type 2 diabetes and complications can be accepted if they were adequately prepared by a proper metabolic treatment, and their weight loss had become apparent.

Hypoendocrinopathies other than diabetes mellitus: Only those adult patients are accepted that no longer respond to a standard hormone replacement therapy. This usually applies to autoimmune diseases: Hashimoto’s thyroiditis, Addison’s disease, etc. All children are accepted as they usually suffer from genetic diseases, and there is no alternative treatment.

Premature ovarian failure: All patients that no longer respond to a standard hormone replacement therapy are accepted, i.e. approximately one half of such patients.

Male hypogonadism: All patients are accepted, as there is no other treatment available, but the treatment has to be carried out in cooperation with an up-to-date infertility center.

Myocardial infarction: if patient is brought in the acute stage to the center of invasive cardiology and the center has an established fetal precursor cell transplantation program, all patients should have a coronary catheterization, stent placement, followed in selected patients by intracoronary implantation of fetal cell transplants.

If no treatment given in the acute stage, then a standard kind of implantation of fetal precursor cell transplants should be carried out four weeks later.

Patients in the acute stage of cerebrovascular accident will hopefully be treated in the same way in the near future. Today a neurosurgical operation has to be carried out as described in the chapter on neurological diseases.

Hypofunction of the immune system: All patients are accepted, as well as children with inborn hypofunction of the immune system of any etiology, for whom there is no alternative treatment.

Autoimmune diseases: All patients in whom the standard treatment no longer works are accepted.

Some chronic diseases of the digestive system (see the chapter on Digestive system diseases): All patients in whom the routine treatment no longer works are accepted.

Aging disease: All patients over the age of 45 are accepted.

Non-healing fractures, and other non-healing bone diseases: All patients, unless they have a ‘florid’ osteomyelitis which requires an aggressive antibiotic treatment, are accepted. This would usually happen, when the orthopedic surgeon has ‘run out of options’. – The same applies to all other diseases with non-healing bone destruction.

Mental retardation: All patients are accepted as there is no alternative therapy. The treatment has to be started as soon as possible after the diagnosis was made

Genetic, chromosomal, and other inborn diseases: All patients are accepted as there is no other treatment. After a possibility of such diagnosis is suggested, fetal precursor cell transplantation must be started without delay, and repeated every 4 months, even if the exact diagnosis has not been established yet.

After there is a suspicion of the brain damage in the newborn, a CT scan of the brain must be made without delay. Whenever there is a periventricular leukomalacia found (often combined with intraventricular bleeding), fetal precursor cell transplantation should be started immediately, and repeated every 4 months. Time must not be wasted for the establishment of an exact diagnosis.

Contra-indications:Terminal stage of a chronic disease is an absolute contraindication. Moribund patients laying in vegetable position for years must not be treated with fetal cell transplantation.

The same does not apply to patients in recent coma, as the reported experience of F. Schmid with treatment of apallic syndrome in children and our own experience with the treatment of recently comatose patients by intrathecal implantation of fetal precursor cell transplants proves beyond doubt. All temporary contraindications, such as:

- acute infection,

- untreated chronic infection,- uncontrollable severe hypertension,

- uncontrollable severe allergic status,

- severe acute exhaustion,

can be removed by appropriate medical treatment.

Acute infections are a problem with small children with genetic and chromosomal diseases coming in for the fetal precursor cell transplantation treatment from a distance, as they frequently get upper respiratory infection during travel. Since the parents often do not have the time to wait for the intercurrent infection to run its course, there is a pressure on the physician to take an action. In author’s experience if the patient is not toxic, and fever not excessively high, the injection of an appropriate antibiotic permits that fetal precursor cell transplantation be carried out after a few hours without any ill consequences for the patient or implanted cell transplants.

Untreated chronic infections are the notorious troublemakers when patient was accepted for fetal precursor cell transplantation. There are hardly any adult patients without a hidden ‘silent’ chronic infection somewhere in the body, and the same applies to many children as well. It happens infrequently only, but certain patients do get a flare-up of their dormant chronic inflammation in the immediate post-SCT course.

It is mandatory to ask every patient about any non-symptomatic chronic infections during the history taking, and then check the current status of such chronic inflammations, and complete an appropriate treatment before the start of preparation of the batch of fetal precursor cell transplants for the patient treatment.

Acute exhaustion is a major issue with some patients suffering from ‘manager syndrome’ that consider fetal precursor cell transplantation a quick way to ‘re-charge their batteries’. If a patient cannot stay at full rest for 3 days, without cell phone, and with a minimum of visitors, and then be prepared for another 7 days of decreased activity, i.e. to follow the post-FCT instructions, it is better not to accept such patient for fetal cell transplantation treatment.