50 patients from each participating hospital that will receive Omega-3 supplementation (300-400mg EPA & 200-300mg DHA) per day for 8 consecutive months up to 10 months.
in addition to experimental treatment this group will receive the traditional treatment of deferoxamine/deferasirox plus regular blood transfusion with dose de-escalation methods till efficacy of experimental treatment proved.

50 patients from each participating hospital that will receive Nigella sativa supplementation (1g black seed oil contain 1% thymoquinone) per day for 8 consecutive months up to 10 months.
in addition to experimental treatment this group will receive the traditional treatment of deferoxamine/deferasirox plus regular blood transfusion with dose de-escalation methods till efficacy of experimental treatment proved.

50 patients from each participating hospital that will receive hydroxyurea medication (5 to 15mg/kg) per day for 8 consecutive months up to 10 months.
in addition to the experimental treatment, this group will receive the traditional treatment of deferoxamine/deferasirox plus regular blood transfusion with dose de-escalation methods until the efficacy of experimental treatment proved.

50 patients from each participating hospital that will receive natural honey(2.5 mg/kg dissolved in 250 ml water) per day for 8 consecutive months up to 10 months.
in addition to the experimental treatment, this group will receive the traditional treatment of deferoxamine/deferasirox plus regular blood transfusion with dose de-escalation methods until the efficacy of experimental treatment proved.

50 patients from each participating hospital that will receive the ordinary treatment of iron chelator agent of deferoxamine or deferasirox (SubQ infusion: 20 to 40 mg/kg/day over 8 to 12 hours, 6 to 7 nights per week, maximum daily dose: 40 mg/kg/day)for 8 consecutive months up to 10 months.
in addition to iron chelator agent, this group receive regular blood transfusion session.

Iron Overload

Oxidative Stress

Thalassemia Major

Omega-3 supplementation (300-400mg EPA & 200-300mg DHA) per day for 8 consecutive months up to 10 months

Omega 3

Nigella sativa supplementation (1g black seed oil contain 1% thymoquinone) per day for 8 consecutive months up to 10 months

Nigella Sativa Oil

hydroxyurea medication (5 to 15mg/kg) per day for 8 consecutive months up to 10 months.

Hydroxyurea

Natural honey(2.5 mg/kg dissolved in 250 ml water) per day for 8 consecutive months up to 10 months.

Honey

deferoxamine (SubQ infusion: 20 to 40 mg/kg/day over 8 to 12 hours, 6 to 7 nights per week, maximum daily dose: 40 mg/kg/day)for 8 consecutive months up to 10 months.

Deferoxamine

Regular blood transfusion session based on patient hematological profile starts from one session every 2 weeks.

blood transfusion session

Faculty of medicine, Beni-suef univeristy - Beni-Suef university hospital

Faculty of Pharmacy, Beni-Suef university

Health insurance hospital

Maternity and Children hospital

Hydroxy Urea, Omega 3, Nigella Sativa,Honey on Oxidative Stress and Iron Chelation in Pediatric Major Thalassemia

Impact of Combination Therapy Between Hydroxy Urea, Omega 3, Nigella Sativa and Honey on Antioxidant-oxidant Status and Reduction of Iron Overload in Pediatric Major Thalassemia

plasma F 2 -isoprostanes Picograms Per Millilitre measured by high pressure liquid chromatography assay

Total cholesterol milligrams per deciliter

Serum total iron micrograms per decilitre

C-reactive protein milligrams per deciliter

Total Iron Binding Capacity micrograms per decilitre

mean corpuscular hemoglobin (MCH) Picograms Per Millilitre

Chelation activity of Ferric - thymoquinone complex in percentage measured by high pressure liquid chromatography coupled with gaschromatography - mass spectroscopy analysis

Chelation activity of Ferrous - thymoquinone complex in percentage measured by high pressure liquid chromatography coupled with gaschromatography- mass spectroscopy analysis

Lactic acid dehydrogenase unit per litter

hemoglobin- F level in gram per deciliter

Reticulocyte absolute count in a cubic milliliter of blood

White blood cells count in a cubic milliliter of blood

Mohamed Medhat Abdelwahab Gamaleldin

Dr.Mohamed Medhat Abdelwahab Gamaleldin

Beni-Suef University

Maternity and Children Hospital, Makkah

Department of clinical pharmacy, faculty of pharmacy, Beni-suef univeristy

Beni-Suef Health insurance hospital

University of Arizona

College of Pharmacy,Department of Pharmacy Practice,University of Arizona

Four experimental groups, one control group.
Each experimental group receives different experimental treatments plus traditional treatment in the hospital and the control group receives only traditional treatment.

Patients will receive a pre-transplant conditioning regimen of Busulfan Fludarabine and Alemtuzumab. For patients with pre-transplant hepatic dysfunction, Melphalan will be substituted for the Busulfan. For patients receiving a second transplant or a "boost", pre-transplant conditioning based on the clinical condition of the patient will be determined by the Principal Investigator and the patient's bone marrow transplantation (BMT) physician. The donor peripheral blood stem cells will undergo CD34+ selection (Biological/Vaccine: CD34 Stem Cell Selection Therapy). The CliniMACS (PLUS) Reagent System will be used to remove T-cells from the peripheral blood stem cell transplant in order to decrease the risk of acute and chronic graft versus host disease (GVHD).

Bone Marrow Failure Syndrome

Severe Aplastic Anemia

Severe Congenital Neutropenia

Amegakaryocytic Thrombocytopenia

Diamond-Blackfan Anemia

Schwachman Diamond Syndrome

Primary Immunodeficiency Syndromes

Acquired Immunodeficiency Syndromes

Histiocytic Syndrome

Familial Hemophagocytic Lymphocytosis

Lymphohistiocytosis

Macrophage Activation Syndrome

Langerhans Cell Histiocytosis (LCH)

Hemoglobinopathies

Sickle Cell Disease

Sickle Cell-beta-thalassemia

The CliniMACS (PLUS) Reagent System (Miltenyi CliniMACS CD34+ Cell Selection Device) will be used to remove T-cells from the peripheral blood stem cell transplant in order to decrease the risk of acute and chronic graft versus host disease (GVHD).

CD34 Stem Cell Selection Therapy

Morgan Stanley Children's Hospital, New York-Presbyterian, Columbia University

CD34+ (Non-Malignant) Stem Cell Selection for Patients Receiving Allogeneic Stem Cell Transplantation

CD34+ Stem Cell Selection for Patients Receiving a Matched or Partially Matched Family or Unrelated Adult Donor Allogeneic Stem Cell Transplantation for Non-Malignant Disease

Determine the incidence and severity of acute GVHD.

Quantify the incidence of primary and secondary graft failure.

To assess event free survival and overall survival

To determine the time to neutrophil and platelet engraftment

To determine the time to immune reconstitution (including normalization of T, B and NK cell repertoire and Immunoglobulin G production)

To establish the incidence of infectious complications including bacterial, viral, fungal and atypical mycobacterial and other infections

beta-thalassemia/пролив

Hydroxy Urea, Omega 3, Nigella Sativa,Honey on Oxidative Stress and Iron Chelation in Pediatric Major Thalassemia

CD34+ (Non-Malignant) Stem Cell Selection for Patients Receiving Allogeneic Stem Cell Transplantation

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