- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01571817
Pancreatic Islet Transplantation Into the Gastric Submucosa
Treatment of Type I Diabetes by Pancreatic Islet Transplantation Into The Gastric Submucosa
연구 개요
상세 설명
The overall objective of this pilot project is to evaluate the safety and efficacy of the gastric submucosal space as a novel site for clinical islet transplantation. Safety will be evaluated by the monitoring of side effects such as post procedural GI complications, frequency of hypo and hyperglycemic events, and immunosuppression side effects. Efficacy will be determined by accepted measures including insulin independence, long term glucose control, and reduction/elimination of hypoglycemic events.
The site has several physiologic attributes that may improve the outcomes of islet transplantation compared with the conventional intraportal transplant site.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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California
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San Francisco, California, 미국, 94143
- University of California, San Francisco
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Key Inclusion Criteria:
- Primary islet allotransplant
- Type I diabetes mellitus for a minimum of 5 years
One or more of the following signs or symptoms despite intensive efforts made in close cooperation with their diabetic care team:
- Metabolic lability/instability characterized by hypoglycemia or ketoacidosis (>2 hospital admissions in the previous year), erratic glucose profiles (MAGE>120 mg/dL), or disruption in lifestyle of danger to life, self or others
- Reduced awareness of hypoglycemia or >1 episode in the last 1.5 years of severe hypoglycemia
- Persistently poor glucose control (as defined by HgbA1c>10% at the end of six months of Intensive management efforts with the diabetes care team)
- Progressive secondary complications as defined by (i) a new proliferative retinopathy or clinically significant macular edema or therapy with photocoagulation during the last year; or (ii) symptomatic autonomic neuropathy (as defined by postural hypotension or neuropathic bladder)
- Age 18 and older
- Patients who have a renal transplant must have received their transplant at least 3 months previously and must have stable renal function (see exclusion criteria below)
- Must be able to give written informed consent
Exclusion Criteria:
Key Exclusion Criteria:
- Lymphopenia (<1000/µL) or leukopenia ( <3000 total leukocytes/µL)
- Presence of panel-reactive anti-HLA antibody >20%
- Positive lymphocytotoxic cross-match using donor lymphocytes and serum
- Evidence of acute EBV infection (IgM>IgG) OR no serologic evidence of previous exposure to EBV (IgG>IgM)
- Calculated or measured GFR < 50 ml/min/m2 in patients without a renal transplant.
- Calculated or measured GFR < 40 ml/min/m2 in patients with a renal transplant.
- Portal hypertension or history of significant liver disease
- History of malignancy within 10 years (except for treated basal or squamous cell CA of the skin)
- Active peptic ulcer disease or other gastric mucosal abnormalities as identified on screening endoscopy
- Severe unremitting diarrhea or other GI disorders potentially interfering with the ability to absorb oral medications
- Untreated proliferative retinopathy
- Pregnancy or breastfeeding
- Female subjects not post-menopausal or surgically sterile who are sexually active but not using an acceptable method of contraception
- Active infections
- Serologic evidence of infection with HIV, or HbsAg or HCV Ab positive
- Major ongoing psychiatric illness
- Ongoing substance abuse, drug or alcohol; or recent history of noncompliance
Any condition that in the opinion of the Principal Investigator does not allow safe participation in the study
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공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Study intervention
endoscopically-guided intestinal submucosal transplantation of Isolated Human Pancreatic Islets in a type 1 diabetic patient
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
기간: Six months
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Hypo- and Hyper-glycemia limits for blood glucose related risks; during procedure, abdominal pain, duodenal hemorrhage, and duodenal perforation post-procedure, fever, cytokine release syndrome (to the thymoglobulin), immunosuppression related issues
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Six months
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Andrew M Posselt, M.D., Ph.D., University of California, San Francisco
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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