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Thursday 17 May 2012, 10:51

Biohellenika’s laboratories support AUTOLOGOUS STEM CELL THERAPY CLINICAL TRIALS
Friday, 27 May 2011 21:47

Biohellenika’s laboratories, in collaboration with University and private sector clinics in Greece and neighboring countries are presently support several stem cell clinical trials that are under development.

Ischemic brain injury that has been implicated in ailments, like cerebral palsy and autism is a promising target for autologous stem cell therapy.

In the case of cerebral palsy, it is presently widely accepted that autologous cord blood stem cell administration may be the only hope for cure. There are two known clinical trials under development, one at the University of Duke and one at the University of Georgia USA and several reports on benefited children can be found on the internet. Umbilical cord stem cell family banks are presently reviewing the costumer medical records, in order to inform the prudential parents of children with cerebral palsy for this new hope for children up to 12 years who have their umbilical cord blood stored.


Two autologous samples processed and stored in Biohellenika’s laboratories have been already used by children with cerebral palsy. The cells have been administered to the young patients without any complication at the Duke University Pediatric Hematology Clinic and the children have been included in the clinical trial that takes place in this university. Three months after therapy the parents reported remarkable improvement for both children. It should be noted that independent quality controls at the University of Duke verified the high quality of cells stored by Biohellenika. Cells viability after post-thaw was higher than 95% in both cases and the minimal amount of DMSO contained in the samples required no washes and was tolerated without any side effect by the patients. In the second case the amount of cells stored exceeded by far the required therapeutic dose and therefore one of the cryovials has been stored at Duke, for future use.


Considering cerebral palsy, Biohellenika is supporting a prospective clinical trial that has been initiated by the neonatology clinic Hipocration Hospital at the University of Thessaloniki. In this case Biohellenika will store for free the umbilical cord blood for every child born with a high possibility to develop cerebral palsy. Prognostic markers will be investigated in the blood of these children. The children will be observed for the next two years for the development of cerebral palsy and cord blood stem cells will then be administered therapeutically to the children, who will develop the disease.


In the case of autism, there are several anecdotal cases and reports about children who benefitted from stem cell therapy, but no known clinical trials are under development. Biohellenika supported, free of charge, the therapy of a child, whose father, a widely respected cardiologist in Athens, insisted to try this option for his autistic son. The child was treated in Nikea General Hospital in Piraeus and was supported by TAKE IE, the joint venture Hellenic National Research Foundation – Biohellenika’s laboratories in Athens. In this case, mesenchymal stem cells derived from the child’s own adipose tissue have been used. The father was enthusiastic about the results of the therapy and these results are scheduled to initiate a large official clinical trial, up on license. Currently there is no known successive cure for autism, therefore stem cell therapy may be a new hope for these children and their families.


Considering adipose tissue derived stem cells, Biohellenika is supporting, free of charge, a clinical trial initiated by the Pulmonary Disease Department in Democritus University Hospital in Alexandroupolis, where autologus adipose tissue derived stem cells are used for the treatment of pulmonary fibrosis, a disease with very short life expectancy upon diagnosis and no known efficient cure. The first results indicated a marginal amelioration in gas exchange indices.


Another clinical trial supported by Biohellenika is under development in the cardiovascular surgery clinic, AHEPA Hospital Aristotle University Thessaloniki. In this case, bone marrow derived stem cells are separated in the laboratories of Biohellenika and injected during an open heart operation around the infracted myocardium areas. In two patients with last stage cardiac insufficiency, a cardiac support pump has been also used to support cardiac function until recovery. Ten patients have been treated up today and no one of them had complications or side effects or arrythmias. Considerable improvement has been reported for some of the patients.


Recently one of the children that had stem cells stored in Biohellenika has been reported to suffer from acute myeloblastic leukemia (AML). This kind of leukemia is rare for the age of 18 months, where acute lymphoblastic leukaemia (ALL) is commonly expected. Examinations on bone marrow aspirate of the patient, indicated no specific mutations that could lead to leukaemia, but many chromosomes multiplications, like trisomies, among them trisomy 8, a chromosomal abnormality that can be the cause of AML. Considering this information, a small fraction of the patients’ stored stem cells was examined by an independent laboratory. Stem cells were found healthy with no trisomy 8 or other chromosomic or genetic mutations that could lead to leukemia. Therefore the doctors can now consider the child’s own stem cells for transplantation upon request.


The examination of the patients’ umbilical cord stem cells, an examination that can be done only if the stem cells have been stored privately, indicated that whatever caused leukemia was not present in hematopoietic stem cells at birth. These results are in accordance with past similar observations, indicating that cord blood stem cells stored at birth can be used for autologous hematopoietic transplantation, if needed to treat infant leukemia (Hayani et al 2007). In such cases umbilical cord blood storage can replace the expensive and apprehensive search for a “compatible” sample that, although “compatible” cannot exclude the possibility of the life threatening graft versus host disease.

Biohellenika’s laboratories, in collaboration with University and private sector clinics in Greece and neighboring countries are presently support several stem cell clinical trials that are under development.


Ischemic brain injury that has been implicated in ailments, like cerebral palsy and autism is a promising target for autologous stem cell therapy.


In the case of cerebral palsy, it is presently widely accepted that autologous cord blood stem cell administration may be the only hope for cure. There are two known clinical trials under development, one at the University of Duke and one at the University of Georgia USA and several reports on benefited children can be found on the internet. Umbilical cord stem cell family banks are presently reviewing the costumer medical records, in order to inform the prudential parents of children with cerebral palsy for this new hope for children up to 12 years who have their umbilical cord blood stored.


Two autologous samples processed and stored in Biohellenika’s laboratories have been already used by children with cerebral palsy. The cells have been administered to the young patients without any complication at the Duke University Pediatric Hematology Clinic and the children have been included in the clinical trial that takes place in this university. Three months after therapy the parents reported remarkable improvement for both children. It should be noted that independent quality controls at the University of Duke verified the high quality of cells stored by Biohellenika. Cells viability after post-thaw was higher than 95% in both cases and the minimal amount of DMSO contained in the samples required no washes and was tolerated without any side effect by the patients. In the second case the amount of cells stored exceeded by far the required therapeutic dose and therefore one of the cryovials has been stored at Duke, for future use.


Considering cerebral palsy, Biohellenika is supporting a prospective clinical trial that has been initiated by the neonatology clinic Hipocration Hospital at the University of Thessaloniki. In this case Biohellenika will store for free the umbilical cord blood for every child born with a high possibility to develop cerebral palsy. Prognostic markers will be investigated in the blood of these children. The children will be observed for the next two years for the development of cerebral palsy and cord blood stem cells will then be administered therapeutically to the children, who will develop the disease.


In the case of autism, there are several anecdotal cases and reports about children who benefitted from stem cell therapy, but no known clinical trials are under development. Biohellenika supported, free of charge, the therapy of a child, whose father, a widely respected cardiologist in Athens, insisted to try this option for his autistic son. The child was treated in Nikea General Hospital in Piraeus and was supported by TAKE IE, the joint venture Hellenic National Research Foundation – Biohellenika’s laboratories in Athens. In this case, mesenchymal stem cells derived from the child’s own adipose tissue have been used. The father was enthusiastic about the results of the therapy and these results are scheduled to initiate a large official clinical trial, up on license. Currently there is no known successive cure for autism, therefore stem cell therapy may be a new hope for these children and their families.


Considering adipose tissue derived stem cells, Biohellenika is supporting, free of charge, a clinical trial initiated by the Pulmonary Disease Department in Democritus University Hospital in Alexandroupolis, where autologus adipose tissue derived stem cells are used for the treatment of pulmonary fibrosis, a disease with very short life expectancy upon diagnosis and no known efficient cure. The first results indicated a marginal amelioration in gas exchange indices.


Another clinical trial supported by Biohellenika is under development in the cardiovascular surgery clinic, AHEPA Hospital Aristotle University Thessaloniki. In this case, bone marrow derived stem cells are separated in the laboratories of Biohellenika and injected during an open heart operation around the infracted myocardium areas. In two patients with last stage cardiac insufficiency, a cardiac support pump has been also used to support cardiac function until recovery. Ten patients have been treated up today and no one of them had complications or side effects or arrythmias. Considerable improvement has been reported for some of the patients.


Recently one of the children that had stem cells stored in Biohellenika has been reported to suffer from acute myeloblastic leukemia (AML). This kind of leukemia is rare for the age of 18 months, where acute lymphoblastic leukaemia (ALL) is commonly expected. Examinations on bone marrow aspirate of the patient, indicated no specific mutations that could lead to leukaemia, but many chromosomes multiplications, like trisomies, among them trisomy 8, a chromosomal abnormality that can be the cause of AML. Considering this information, a small fraction of the patients’ stored stem cells was examined by an independent laboratory. Stem cells were found healthy with no trisomy 8 or other chromosomic or genetic mutations that could lead to leukemia. Therefore the doctors can now consider the child’s own stem cells for transplantation upon request.


The examination of the patients’ umbilical cord stem cells, an examination that can be done only if the stem cells have been stored privately, indicated that whatever caused leukemia was not present in hematopoietic stem cells at birth. These results are in accordance with past similar observations, indicating that cord blood stem cells stored at birth can be used for autologous hematopoietic transplantation, if needed to treat infant leukemia (Hayani et al 2007). In such cases umbilical cord blood storage can replace the expensive and apprehensive search for a “compatible” sample that, although “compatible” cannot exclude the possibility of the life threatening graft versus host disease.

 

Therapeutic potential of non-embryonic autologus stem cells and the justification for stem cell banking.



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