- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01571817
Pancreatic Islet Transplantation Into the Gastric Submucosa
Treatment of Type I Diabetes by Pancreatic Islet Transplantation Into The Gastric Submucosa
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 1
Kontakte und Standorte
Studienorte
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California
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San Francisco, California, Vereinigte Staaten, 94143
- University of California, San Francisco
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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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Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Study intervention
endoscopically-guided intestinal submucosal transplantation of Isolated Human Pancreatic Islets in a type 1 diabetic patient
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Zeitfenster: Six months
|
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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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Andrew M Posselt, M.D., Ph.D., University of California, San Francisco
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Islet-Tx-Sub-DERC
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