ASIS Corporation (ASIS) has developed the only automatic injection system for delivery of injectable products to it's optimum/right spot, just outside of the fascia, which exists subdermally (between the skin and muscle). Bloodless basically implies longer lasting medicinal effects, and minimal side effects - advantages that reflect the NIH mission of enhancing health, lengthening life, and reducing the burdens of illness and disability. ASIS device is stabilized on the surface of the skin with negative pressure and emits an electrical current to create a bloodless cavity subdermally. ASIS device correctly, automatically, and consistently delivers therapeutic agents, yet requiring little skill of a practitioner - providing the steady and safe infusion into subdermal bloodless space of virtually any injectable product in addition to Botox, including GAMMAGARD LIQUID, Enbrel, Insulin, and Fillers, etc. According to the FDA, "This innovation will have major impact on the healthcare industry."
Aim 1 would require 6 months, to demonstrate ASIS device's consistent performance on 60 subjects with Primary Immunodeficiency (PI), and the particular skin affected by this disease. 30 subjects will receive Gadolinium subcutaneously, and 30 subjects will receive Gadolinium subdermally with ASIS device. An MRI will be taken promptly after Gadolinium injection, as starting reference, to which subsequent MRI taken at 6 hrs, 12 hrs, and 24 hrs later will be compared for Persistent %. Since there isn't a way to measure level of Gadolinium within it, or any other (e.g. GAMMAGARD) for that matter, at least the Prolongation of Gadolinium may be approximated by the greater or longer Persistent % on MRI. However, this approximation can only work if the variables are minimized to the same population with Primary Immunodeficiency (PI), and the particular skin affected by it. Case in point, Primary Immunodeficiency (PI) patients are prone to infection, and tend to have scared skin with less vascularity, so expectantly will have prolonged Gadolinium subcutaneously Persistent %, which will be very different from the skin of normal patients, while the Gadolinium subdermally Persistent % may or may not change. Therefore, the Relative Prolongation Ability Score or total Persistent % subdermally over that of total Persistent % subcutaneously, will be different and very specific for the particular skin affected by Primary Immunodeficiency. However, they are valuable indicators that will help us modify the GAMMAGARD dosage and duration to inject into that "unknown" subdermal space for Aim 2. Aim 2 would require 12 months, using GAMMAGARD, instead of Gadolinium, to demonstrate the advantages of ASIS device subdermally over subcutaneously, for the same Primary Immunodeficiency subjects. Of course that Relative Prolongation Ability Score in Aim1 will be valuable, but it isn't absolutely required to start Aim 2, because GAMMAGARD's Pharmacokinetics will be studied anyway, by following Peak and Trough levels of immunoglobulin G. However, the Pharmacokinetics of subdermally injected GAMMAGARD will be just dependent on GAMMAGARD's diffusion out of that subdermal bloodless space; therefore, if GAMMAGARD getting into the bloodstream becomes so severely inhibited, then we can just change the osmolality of GAMMAGARD in the end. The therapeutic advantages of GAMMAGARD with ASIS device subdermally over subcutaneously will also be studied by comparing the reduction of Validated Acute Serious Bacterial Infections, adverse reactions, and injection site pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Gadolinium 1cc/ diluted with 19cc normal saline (for \<40kg) or 29cc normal saline (for \>40kg) subdermally with ASIS Device for 30 patients. Gadolinium For abdomen Total Persistent % subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs.
Gadolinium 1cc/ diluted with 19cc normal saline (for \<40kg) or 29cc normal saline (for \>40kg) subcutaneously for 30 patients. Gadolinium For abdomen Total Persistent % subcutaneously on MRI at 6 hrs, 12 hrs, and 24 hrs.
Gadolinium For abdomen Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium subcutaneously on MRI.
Gadolinium For lower back Total Persistent % subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs. Gadolinium 1cc/ diluted with 19cc normal saline (for \<40kg) or 29cc normal saline (for \>40kg) subdermally with ASIS Device for 30 patients.
Gadolinium For lower back Total cumulative Persistent % of Gadolinium subcutaneously on MRI at 6 hrs, 12 hrs, and 24 hrs. Gadolinium 1cc/ diluted with 19cc normal saline (for \<40kg) or 29cc normal saline (for \>40kg) subcutaneously for 30 patients.
Gadolinium For lower back Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium subcutaneously on MRI .
subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 12.
Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 12.
subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 24.
Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 24.
subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 24.
Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 24
(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 36.
Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 36.
subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 12
Annual rate of any infections as Efficacy of Gammagard subdermally at Week 12
subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 12
Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 12
(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 12
Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 12.
subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 24.
Annual rate of any infections as Efficacy of Gammagard subdermally at Week 24.
subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 24.
Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 24.
(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 36.
Annual rate of any infections as Efficacy of Gammagard subdermally at Week 36.
subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 36.
Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 36.
(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
Adverse Reactions of Gammagard subcutaneously at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Adverse Reactions of Gammagard subcutaneously at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Adverse Reactions of Gammagard subcutaneously at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Adverse Reactions of Gammagard subdermally at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain
Adverse Reactions of Gammagard subdermally at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Adverse Reactions of Gammagard subdermally at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Automatic Subdermal Injector System, Inc
Westminster, California, United States
Relative Prolongation Ability Score for Gadolinium subdermally injected
Gadolinium will be injected with ASIS subdermally (30) or conventional subcutaneous (30) for 60 adult subjects with Primary Immunodeficiency. The first MRI taken promptly after Gadolinium injection for each patient would be his or her reference of 100% Persistent, to which his or her subsequent MRI taken @ 6 hr, @ 12 hr, and @24hr later will be compared for Persistent %. This approximation can only work if the variables are minimized to the same population with Primary Immunodeficiency. The Relative Prolongation Ability Score or total Persistent % subdermally over total Persistent % subcutaneously, in Primary Immunodeficiency will be very valuable indicators for us to modify the GAMMAGARD dosage and duration for testing with that "unknown" subdermal bloodless space in Aim 2.
Time frame: 6 months
Efficacy of GAMMAGARD subcutaneously vs. subdermally in Primary Immunodeficiency
The therapeutic efficacy of GAMMAGARD, in terms of reduction of Validated Acute Serious Bacterial Infections will be compared, eg. subjects (%) and Annual rate of any infections, subjects (%) and Annual rate of Antibiotic use, subjects (%) and Annual rate with Days out of work, subjects (%) and Annual rate of hospitalized infections, to demonstrate the advantages of ASIS device subdermally over subcutaneously for GAMMAGARD at Week 12, 24, and 36.
Time frame: 12 months
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