ASIS for GAMMAGARD in Primary Immunodeficiency
| Status: | Not yet recruiting |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 21 - 65 |
| Updated: | 4/2/2016 |
| Start Date: | January 2016 |
| End Date: | June 2016 |
| Contact: | Li Nguyen, MD |
| Email: | dr.li.nguyen@asis-inc.com |
| Phone: | (714)-453-7857 |
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."
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.
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.
Inclusion Criteria:
- Inclusion Criteria in general and for Gadolinium:
- Main Criteria for Inclusion: Eligible Ages: 12 Years to 65
- Genders Eligible for Study: Both
- Accepts Healthy Volunteers: Yes
- Must be outpatient, male or female, of any race, between 18 and 65 years of age.
- Must be able to understand the requirements of the study including maintaining a
diary, and sign informed consent.
- Must be in good general health as determined by investigator.
- If female of childbearing potential, must have negative pregnancy test result at
screening visit and practice reliable method of contraception
- Inclusion Criteria for Primary Immunodeficiency in particular:
- Patients 12 years or older. This includes, but is not limited to, common
variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital
agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined
immunodeficiencies1,2.
Exclusion Criteria:
- Exclusion Criteria for Primary Immunodeficiency in particular:
- Females who are pregnant, nursing, or planning a pregnancy during the study
period or who are not using a reliable means of contraception.
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