Personalized Immunotherapeutics for Antibiotic-resistant Infection
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Arthritis, Infectious Disease, Infectious Disease, HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases, Rheumatology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2016 |
| End Date: | December 2017 |
M. A. suffers from hypogammaglobulinemia that has been complicated by refractory Mycoplasma
hominis septic arthritis. He has been receiving the antibiotic valnemulin under Emergency
Investigational New Drug (eIND) 114686 following many prior treatments with standard
antibiotics. M.A. has also been receiving intravenous immunoglobulin (IVIG) replacement. The
antibiotic and IVIG have been helpful, but not sufficient for cure. Antibodies have been
shown to be critical for defense against mycoplasma. Hyperimmune serum against mycoplasma
isolated from rabbit or goat has been effective in cases of chronic erosive arthritis in the
setting of immune deficiency, and in some cases resulted in cures. The investigators propose
to use M. hominis isolated from M. A. to vaccinate one transgenic cow (developed by SAB
Biotherapeutics), purify human antibody after vaccination, test the purified antibody in
killing assays to confirm potency, and then administer the purified human IgG to M. A. after
FDA compassionate use IND application and local Institutional Review Board (IRB) approval.
hominis septic arthritis. He has been receiving the antibiotic valnemulin under Emergency
Investigational New Drug (eIND) 114686 following many prior treatments with standard
antibiotics. M.A. has also been receiving intravenous immunoglobulin (IVIG) replacement. The
antibiotic and IVIG have been helpful, but not sufficient for cure. Antibodies have been
shown to be critical for defense against mycoplasma. Hyperimmune serum against mycoplasma
isolated from rabbit or goat has been effective in cases of chronic erosive arthritis in the
setting of immune deficiency, and in some cases resulted in cures. The investigators propose
to use M. hominis isolated from M. A. to vaccinate one transgenic cow (developed by SAB
Biotherapeutics), purify human antibody after vaccination, test the purified antibody in
killing assays to confirm potency, and then administer the purified human IgG to M. A. after
FDA compassionate use IND application and local Institutional Review Board (IRB) approval.
M. A. suffers from hypogammaglobulinemia that has been complicated by refractory Mycoplasma
hominis septic arthritis. He has been receiving the antibiotic valnemulin under Emergency
Investigational New Drug (eIND) 114686 following many prior treatments with standard
antibiotics. M.A. has also been receiving intravenous immunoglobulin (IVIG) replacement. The
antibiotic and IVIG have been helpful, but not sufficient for cure.
Antibodies have been shown to be critical for defense against mycoplasma. Hyperimmune serum
against mycoplasma isolated from rabbit or goat has been effective in cases of chronic
erosive arthritis in the setting of immune deficiency, and in some cases resulted in cures.
SAB Biotherapeutics, Inc. (formerly Sanford Applied Biosciences, LLC) located in Sioux
Falls, SD, have developed transchromosomic (Tc) cows containing human immunoglobulin (Ig)
heavy (IgH) and light (IgL) chain loci in the setting of inactivated bovine IgH and Ig
lambda loci. To date, SAB Biotherapeutics (SAB) has several products in development that
have been tested in animal models, but to date no human trials.
Investigators propose to use M. hominis isolated from M. A. to vaccinate one transgenic cow,
purify antibody after vaccination, test the purified antibody in killing assays to confirm
potency, and then administer the purified human IgG to M. A. after FDA compassionate use IND
application and local Institutional Review Board (IRB) approval.
M. A. is a highly educated person with full decision making capacity and is well aware of
the uncertainties and risks associated with this treatment. This proposal is designed to
offer this patient an alternative and perhaps curative approach to his disease.
hominis septic arthritis. He has been receiving the antibiotic valnemulin under Emergency
Investigational New Drug (eIND) 114686 following many prior treatments with standard
antibiotics. M.A. has also been receiving intravenous immunoglobulin (IVIG) replacement. The
antibiotic and IVIG have been helpful, but not sufficient for cure.
Antibodies have been shown to be critical for defense against mycoplasma. Hyperimmune serum
against mycoplasma isolated from rabbit or goat has been effective in cases of chronic
erosive arthritis in the setting of immune deficiency, and in some cases resulted in cures.
SAB Biotherapeutics, Inc. (formerly Sanford Applied Biosciences, LLC) located in Sioux
Falls, SD, have developed transchromosomic (Tc) cows containing human immunoglobulin (Ig)
heavy (IgH) and light (IgL) chain loci in the setting of inactivated bovine IgH and Ig
lambda loci. To date, SAB Biotherapeutics (SAB) has several products in development that
have been tested in animal models, but to date no human trials.
Investigators propose to use M. hominis isolated from M. A. to vaccinate one transgenic cow,
purify antibody after vaccination, test the purified antibody in killing assays to confirm
potency, and then administer the purified human IgG to M. A. after FDA compassionate use IND
application and local Institutional Review Board (IRB) approval.
M. A. is a highly educated person with full decision making capacity and is well aware of
the uncertainties and risks associated with this treatment. This proposal is designed to
offer this patient an alternative and perhaps curative approach to his disease.
Inclusion Criteria:
- Adult with decision making capacity afflicted with chronic mycoplasma hominis septic
arthritis despite standard treatments.
Exclusion Criteria:
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