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 Treatment of Incurable, Life Threatening/Disabling Complications of Diabetes Mellitus by BCRO Cell Transplantation

 

Diabetes mellitus type 1 will reach the stage of life threatening and severely disabling complications the progress of which cannot be controlled by insulin treatment alone

It has been known for three decades that BCRO type of fetal precursor cell transplantation ( cell therapy) is the sole therapy available for such advanced stages of diabetes. Prior to introduction of BCRO type of fetal precursor cell transplantation in 1984 in USSR the success of German cell therapy in treatment of diabetes mellitus and its complications was non-existent.

Already in the 1930 Alexis Carrell, Nobel Prize Winner in medicine, stated that insulin alone cannot cure diabetes mellitus, only a correct type of cell transplantation can.This statement is still valid today - even after widely promoted DCCT clinical trial in the U.S.

Insulin prevents death of a new diabetic, usually a child or juvenile, but cannot stop the development of diabetic complications, severely disabling, and frequently deadly after years of suffering.

The underlying cause of all diabetic complications are micro-angiopathic changes but the etiology of those changes is still not clear, It is not a result of lack of insulin only. There are theories that the severity and chronicity of hyperglycemia leads to

1/ protein glycosylation with irreversible binding of glucose to free amino groups of proteins with creation of advanced glycation end products    or to

2/ increased uptake of glucose by tissues,dependent on insulin, via polyol metabolic pathway that leads to an accumulation of sorbitol in cells and growing cell edema,

and blood vessel obstruction, the real cause of microangiopathic complications of type 1 diabetes.

But it could be a lack of other hormones produced by other cells of Langerhans islets of pancreas, besides glucagon and insulin, or even more likely that this lack of various hormones places undue demands on the regulatory system of carbohydrate and lipid metabolism, primarily on the ‘hypothalamus /pituitary – adrenal axis’, and the liver as the master organ of metabolism, with overload and then inevitable exhaustion of these organs, signaled by the appearance of the diabetic complications.  

The published data about thousands of diabetics that have been handled by BCRO type of fetal precursor cell transplantation in clinical practice with high success rate during the last 30 years speak for themselves. Such data have been about the patients suffering from:

Diabetes Mellitus, types 1 and mixed 1/2, particularly with complications, such as

a. Diabetic Retinopathy

b. Diabetic Nephropathy

c. Diabetic Polyneuropathy

d. Diabetic Arterial Disease, predominantly of lower extremities, but also of brain and heart.  

This applies also to

- Brittle Diabetes Mellitus in children; and

- Diabetes Mellitus in pregnancy, or diabetes mellitus as a cause of female infertility and habitual pregnancy loss.

Bio-Cellular Research Organization Ltd ('BCRO') filed in February 1999 four Investigational New Drug applications with U.S. FDA for the treatment of advanced stages of the life threatening  and severely disabling complications of IDDM ('Insulin Dependent Diabetes Mellitus')

  • Diabetic retinopathy

  • Diabetic nephropathy

  • Diabetic polyneuropathy

  • Diabetic lower extremity arterial disease

by BCRO method of cell transplantation, described in this web site.

As an example, the success rate of treatment by our method of cell transplantation has been for:

  • Diabetic retinopathy in pre-proliferative stage 65%

  • Diabetic nephropathy in pre-uremic stage 60%

  • Diabetic polyneuropathy 98%

  • Diabetic lower extremity arterial disease in pre-gangrene stage 65%.

The sooner the patient receives cell transplantation after the diagnosis of diabetic complication was established, the better will be the success rate of such therapy.

Up to 80% of children with therapeutically uncontrollable 'brittle' diabetes had already developed typical diabetic complications by the time of their referral for cell transplantation, and such patients benefit from such therapy in 85% of cases.

Unknown number of children with recent onset of diabetes mellitus have been treated successfully with cell transplantation: there have been some cures, and in other patients at least a delay in the onset of juvenile diabetic condition. 

If one could postpone the onset of child's diabetes by one or more years, it would be of tremendous value because of well known deleterious effect of diabetic condition on growth and development of such children.

When a woman diabetic has been under treatment for infertility for over a year without a success, BCRO type of cell transplantation should be strongly considered. 

If a woman with diabetes mellitus have had 2 – 3 miscarriages, BCRO type cell transplantation is indicated. 

When a pregnant diabetic delivered a baby with a diabetic fetal distress syndrome, BCRO type of cell transplantation should be carried out before her next pregnancy, or even during her next pregnancy (between 12th and 16th weeks).

(biocell@stem-cell-transplantation.com)

The preparation of cell transplants by BCRO method, that includes a unique programm of primary tissue culture,  lowers the immunogenicity of the cell transplants to such a degree that no immunosuppression is necessary, and that is of great importance particularly for the treatment of diabetes mellitus.  

Besides known side-effects the specific problem of immunosuppression in diabetics is that it causes an increased metabolic demand on beta cells of pancreatic islets so that their capacity to produce insulin may be exhausted. 

This deleterious effect is much greater for islet cell transplants than for organ transplants of pancreas.

As the clinical experience of the past three decades have shown only fetal precursor cell transplantation can stop the relentless progress of the complications of diabetes mellitus once they start. 

Type 2 diabetes mellitus, known as ‘DM of old age’ amounts to 90% of cases worldwide, is a combination of insulin resistance with insufficient compensatory response of beta cell of Langerhans islets of pancreas, frequently going hand in hand with obesity. Type 2 diabetics with complications can be treated by BCRO fetal precursor cell transplantation unless their obesity is pronounced in which cases the results are not good.

According to the National Institute of Health data of April 1, 1998:

  • As many as 15.7 million of U.S. population (~6%) had diabetes mellitus

    of which 7%, it means around 1.1 million, suffered from type 1 (insulin-dependent) diabetes mellitus, 

    and the rest from other types, most commonly type 2 (non-insulin-dependent diabetes mellitus, or NIDDM);

  • Diabetic retinopathy is the leading cause of new cases of blindness of adults in U.S.

    after 15 years of diabetes 97% of IDDM, 80% of insulin-treated NIDDM and 55% of non-insulin treated NIDDM patients will have retinopathy, 

    and around one third of these patients will develop the most severe stage of proliferative retinopathy, leading to blindness;

  • Diabetic nephropathy, the leading cause of end-stage kidney disease in U.S. requiring artificial kidney treatments (hemodialysis)  & kidney organ transplantation, develops in 35% of all diabetics

    after 15 years 25% of diabetics will have protein in urine,

    and of those 50% of IDDM patients and 11% of NIDDM patients will be on kidney dialysis within 10 years;

  • Diabetic polyneuropathy will develop after 15 years in 30 - 70% of diabetics, equally in IDDM and NIDDM patients;

  • Diabetic lower extremity arterial disease has been the cause of one half of all leg amputations in U.S.;

  • Diabetes mellitus is 7th leading cause of death in U.S.: 200,000 deaths reported each year;

  • Diabetics have much higher incidence of heart disease, at an earlier age, and with fatal prognosis, than non-diabetics;

  • Diabetics have 2.5. times higher risk of stroke than non-diabetics;

  • Many digestive diseases, infections, dental problems, depressions, are substantially more common in diabetics than non-diabetics.

The above statistics have gotten worse since 1995

Organ transplantation of pancreas has been carried out for several years, but even today it amounts to only ~ 1,300 patients a year worldwide, because of high complications rate. For that reason it has been usually carried out only in conjunction with kidney transplantation.

BCRO type of fetal precursor cell transplantation,  has been used successfully for 80+ years as treatment of many diseases
  • for which modern medicine has had no therapy (i.e. incurable), or
     
  • in which 'state-of-art' therapies stopped being effective (i.e. no longer treatable),

in documented over 5 millions of patients worldwide. Physicians can learn about it in a textbook by E. Michael Molnar, M.D.: Fetal Precursor Cell Transplantation, BCRO Fetal Precursor Cell Transplantation", published in 2014 by www.amazon.com
On the same web site the general readership can find out all about it in the book by the same author: “Treatment of Incurable and No Longer Treatable Diseases”, published in January 2015, as well as in his autobiography: “Diseases and Genocide are not Our Destiny”. You can buy it as 'free reader download for PC' as well as Kindle Book.

(biocell@stem-cell-transplantation.com)

 

 
 

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Updated: March 2015