CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 2 enrolled
Drug / intervention
Autologous stem cells +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01786707
NCT01786707Phase 2Completed
CompareCT.gov

Phase 2 Study of Autologous Stem Cell and Hyperbaric Oxygen Therapy in Type 2 Diabetes Mellitus

Rodolfo Alejandro·interventional·Posted Feb 8, 2013·Updated Jul 2, 2017

In Brief

A Phase 2 clinical trial evaluating Autologous stem cells, Hyperbaric oxygen therapy, and 2 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 2 participants across 1 site.

Detailed Summary

A prospective, open labeled, randomized controlled clinical trial comparing the benefit of both hyperbaric oxygen therapy and intrapancreatic stem cell infusion to standard medical treatment alone for type 2 diabetes mellitus. Subjects will receive standard medical treatment (SMT) with insulin and metformin for 4 months (evaluation phase). Then they will be randomized into either the intervention group or the control group:

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesUnited States
CollaboratorsDiabetes Research Institute Foundation

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 8, 2013
Enrollment StartJul 1, 2009
Primary CompletionMar 1, 2011
Study CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 13.4 years ago

Interventions

Autologous stem cellsbiological

Pancreatic artery infusion of Autologous Stem cells.

Hyperbaric oxygen therapyother

Insulindrug

Insulin dose as per clinical management

Metformindrug

Metformin dose as tolerated