Shoot Bcg. And observe the results
Bcg works for plaque psoriasis and multiple sclerosis et al
The us values life so much or so little that it made faustman establish the Safety of Bcg in a phase 1 trial
The us and drug companies are severely broken
Morphine producing yeastcoming to a beer distributor near you.
If you have MS. Read pubmed.org RISTORI +Bcg
Speeding up drug-approval process could have downside
May 29, 2015
Consumer advocates have expressed concern that the 21st Century Cures legislation, which would speed up the drug-approval process, could lower standards for approving new uses of existing drugs.
Consumer advocates have expressed concern that the 21st Century Cures legislation, which would speed up the drug-approval process, could lower standards for approving new uses of existing drugs. While supporters say the measure—approved recently by the House Energy and Commerce Committee—has been a long time coming, critics have taken issue with a part of the bill focused on drug development. They note that language in the bill would allow FDA to approve additional uses of drugs without having to rely on randomized, controlled trials. Instead, the bill lists "clinical experience," a combination of observational studies, patient registries, and therapeutic use. "Clinical experience is something that should be considered as additional information, but absolutely never take the place of scientific data," says Diana Zuckerman, heads of the nonprofit National Center for Health Research. "By urging FDA to get away from randomized clinical trials, drug makers may have more power to urge the FDA to consider data that is favorable to their product." The measure does not require FDA to consider such information when reviewing new uses for a drug, but Stanford University School of Medicine's Steve Goodman asserts that using the type of data suggested in the bill could make it hard for FDA to develop guidelines. "This doesn't have to mean the standard of evidence will be lowered, but it potentially opens the door to a weaker standard," he explains.
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Trial record 1 of 2 for: Faustman
Repeat BCG Vaccinations for the Treatment of Established Type 1 Diabetes
Verified May 2015 by Massachusetts General Hospital
Sponsor:
Massachusetts General Hospital
Information provided by (Responsible Party):
Denise Louise Faustman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT02081326
First received: March 4, 2014
Last updated: May 21, 2015
Last verified: May 2015
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Purpose
The purpose of this study is to see if repeat bacillus Calmette-Guérin (BCG) vaccinations can confer a beneficial immune and metabolic effect on Type 1 diabetes. Published Phase I data on repeat BCG vaccinations in long term diabetics showed specific death of some of the disease causing bad white blood cells and also showed a short and small pancreas effect of restored insulin secretion. In this Phase II study, the investigators will attempt to vaccinate more frequently to see if these desirable effects can be more sustained.
Eligible volunteers will either be vaccinated with BCG in a repeat fashion over a period of four years or receive a placebo treatment. The investigators hypothesize that each BCG vaccination will eliminate more and more of the disease causing white blood cells that could offer relief to the pancreas for increased survival and restoration of insulin secretion from the pancreas.
| Condition | Intervention | Phase |
|---|---|---|
| Diabetes Mellitus, Type One Diabetes Mellitus, Type I Autoimmune Diabetes | Biological: Bacillus Calmette-Guérin Biological: Saline injection | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Repeat BCG Vaccinations for the Treatment of Established Type 1 Diabetes |
Resource links provided by NLM:
Genetics Home Reference related topics: type 1 diabetes
MedlinePlus related topics: Diabetes Type 1
Drug Information available for: BCG Vaccine
U.S. FDA Resources
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- Improvement in HbA1c [ Time Frame: 1, 2, 3, 4, and 5 years after initial BCG/placebo injection ] [ Designated as safety issue: No ]An improvement in the hemoglobin A1c (HbA1c) measurement compared to self
Secondary Outcome Measures:
- Change in Immune Response [ Time Frame: 2 and 4 weeks and 1, 2, 3, 4, and 5 years after initial BCG/placebo injection ] [ Designated as safety issue: No ]Beneficial immune changes of autoimmune reversal that may also lead to a change in insulin
Other Outcome Measures:
- Stabilization in Urinary C-peptide [ Time Frame: 1, 2, 3, 4, and 5 years after initial BCG/placebo injection ] [ Designated as safety issue: No ]Stabilization or improvement in urinary c-peptide of BCG treated group as compared to placebo group or self
- Stabilization of Stimulated C-peptide [ Time Frame: 1, 2, 3, 4, and 5 years after initial BCG/placebo injection ] [ Designated as safety issue: No ]Improvement or stabilization in stimulated C-peptide (self insulin) as measured by a mixed meal tolerance test (MMTT) when compared to self or placebo treated group
| Estimated Enrollment: | 150 |
| Study Start Date: | July 2015 |
| Estimated Study Completion Date: | July 2023 |
| Estimated Primary Completion Date: | July 2020 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Bacillus Calmette-Guérin
2 BCG vaccinations spaced 4 weeks apart during the first year and then 1 vaccination every year for the next 4 years
| Biological: Bacillus Calmette-Guérin
2 BCG vaccinations spaced 4 weeks apart during the first year and then 1 vaccination every year for the next 4 years
|
| Placebo Comparator: Saline injection
2 injections spaced 4 weeks apart during the first year, then 1 injection per year for the next 4 years
| Biological: Saline injection
2 injections spaced 4 weeks apart during the first year, then 1 injection per year for the next 4 years
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Type 1 diabetes treated continuously with insulin from time of diagnosis
- Age 18-65
- HIV antibody negative
- Normal CBC
- HCG negative (females)
- Anti-GAD Positive (except for subjects with c-peptide <10pmol/L)
- Fasting or stimulated c-peptide between 5-200 pmol/L
- Participation in protocol #2001P001379, "Autoimmunity: In Vitro Pathogenesis and Early Detection"
Exclusion Criteria:
- History of chronic infectious disease such as HIV or hepatitis
- History of tuberculosis, TB risk factors, positive interferon-gamma release assay (IGRA, also known as the T-SPOT.TB test), or BCG vaccination
- Current treatment with glucocorticoids (other than intermittent nasal or eye steroids), or disease or condition likely to require steroid therapy
- Other conditions or treatments associated with increased risk of infections such as patients with a previous history of severe burns, or treatment with immunosuppressive medications of any type (e.g. imuran, methotrexate, cyclosporine, etanercept, infliximab) for any reason
- Current treatment with aspirin > 160 mg/day or chronic, daily NSAIDs
- Current treatment with antibiotics
- History of keloid formation
- Average HbA1c over the past 5 years (or since diagnosis if duration is less than 5 years) <6.5 or > 8.5%
- History or evidence of chronic kidney disease (serum creatinine > 1.5mg/dL)
- History of proliferative diabetic retinopathy that has not been treated with laser therapy
- History of neuropathy, foot ulcers, amputations, or kidney disease
- Pregnant or not using acceptable birth control
- Living with someone who is immunosuppressed and/or at high risk for infectious diseases (for example HIV+ or taking immunosuppressive medications for any reason)
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