Primary Immunodeficiency Clinical Trial
Official title:
Study of Safety and Efficacy of Mini-pool Intravenous Immunoglobulin (MP-IVIG) Prepared by Assiut University Hospital Blood Bank in Primary Immunodeficiency Patients
1. study the pharmacokinetics of mini-pooled intravenous immunoglobulin( MP-IVIG)
2. Study the safety and efficacy of a newly developed preparation of MP-IVIG in children
with primary immunodeficiency (PID) :
- Adverse reaction of MP-IVIG(anaphylaxis and haemolysis)( no or mild or moderate)
- Prevention of severe bacterial infection
- Improvement of general health(weight gain and mentality)
- Integration in to social live
3. Compare the efficacy of MP-IVIG to standard IVIG in children with primary
immunodeficiency (PID).
Primary immunodeficiency diseases (PID) are a heterogeneous group of inherited disorders of
the immune system, predisposing individuals to recurrent infections, allergy, autoimmunity,
and malignancies. Clinical descriptions have already been made for more than 200 PIDs, for
which over 150 forms of PID have been molecularly characterized .
A population prevalence of diagnosed PID in the United States at approximately 1 in 1,200
persons.
A part from local registration in some centres there is no national registry of PID in Egypt,
and hence, the prevalence of these disorders in the investigator's population is still
unknown .
An increasing number of PID are recognized, and effective treatments are possible. Early use
of prophylactic antibiotics and replacement immunoglobulin can prevent significant end organ
damage and improve long quality of life in these patients .
Immunoglobulin G (IgG) is an essential plasma derived medicine that is lacking in developing
countries .IgG shortages leave immune deficient patients without treatment, exposing them to
devastating recurrent infections from local pathogens. A simple and practical method for
producing IgG from normal plasma collected in developing countries is needed to provide
better, faster access to IgG for patients .
Magdy EL-Ekiaby, et al 2010 introduce the concept of small-scale ("minipool") plasma
processing methods implementable with minimum infrastructural requirements. They developed
viral inactivation and protein purification technologies in single-use equipment to prepare
virally safe solvent/detergent-filtered (S/D-F) plasma Producing a 90%pure immunoglobulin
fraction in disposable single-use devices for transfusion as well as minipool S/D-F
cryoprecipitate to treat bleeding disorders.
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