Diabetes mellitus will frequently reach the stage of life threatening and severely disabling complications the progress of which cannot be controlled by insulin alone. It has been known for decades that fetal precursor cell transplantation is the sole therapy available for such advanced stages of diabetes.
There are published data about several thousands of diabetics that have been so handled in clinical practice with ever growing success during the last 70 years, but the total number of diabetics among ~ 5 million patients that underwent cell therapy is obviously much larger.
Since 1998 we have made our fetal precursor cell transplants available to physicians for treatment of their own patients. This was a result of 35+ years of research, GMP (‘good manufacturing practice’) and clinical experience with fetal precursor cell transplantation in thousands of patients suffering from Diabetes Mellitus, types 1 and mixed 1/2, particularly with complications, such as:
1. Diabetic Retinopathy,
2. Diabetic Nephropathy,
3. Diabetic Polyneuropathy,
4. Diabetic Lower Extremity Arterial Disease.
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 its 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 numbers 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 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
When a woman diabetic has been under treatment for infertility for over a year without a success, cell transplantation should be strongly considered. If a woman with diabetes mellitus has had 2 – 3 miscarriages,
cell transplantation is indicated.
When a pregnant diabetic delivered a baby with a diabetic fetal distress syndrome, cell transplantation should be carried out before her next pregnancy, or even during her next pregnancy (between 12th and 16th week).
The preparation of cell transplants by our method, that includes a unique system 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 well 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.
Already in the 30s, Alexis Carrel, Nobel Prize winner in physiology, stated that insulin cannot cure diabetes mellitus, only cell transplantation can. This statement is still valid today – even after the widely promoted DCCT trial in the U.S. Insulin prevents death of a new diabetic but cannot stop the development of dreaded diabetic complications, severely disabling, and frequently deadly after years of suffering. The cause of all diabetic complications is still unknown but it is probably due to the lack of other – still unknown – hormones produced by various cells of Langerhans islets of pancreas, or by different cells of various organs of the regulatory system of carbohydrate and lipid metabolism.
As the clinical experience of the past four decades have shown only fetal precursor cell transplantation can stop the relentless progress of the complications of diabetes mellitus once they start. This implies that the
transplanted cells of all organs and tissues involved in carbohydrate metabolism produce – directly or indirectly – the missing (endocrine or paracrine) hormones.
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.