Safety and Efficacy of Autologous Adipose-Derived Stem Cell Transplantation in Type 2 Diabetics

June 28, 2008 updated by: Adistem Ltd

Phase I/II Study of Intravenous Administration of Activated Autologous Adipose-Derived Stromal Vascular Fraction in Patients With Type 2 Diabetes

The purpose of this study is to determine whether intravenous administration of autologous adipose-derived stem cells is of benefit in the management of types 2 diabetics.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Diabetes Mellitus is of large epidemic proportions worldwide. It is proliferating at such a fast rate that new novel drugs and other therapeutic approaches are required. The purpose of this Phase 1/Phase 2 study is to determine whether the intavenous administration of activated adipose-derived stromal vascular fraction as a single procedure is safe to and can benefit the disease pathology of patients with Type 2 Diabetes Mellitus (insulin resistance). Patients will be observed over 12 months following the procedure, with a 2 week, 1 month and then tri monthly diagnostics and life style questionaires.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Philippines
    • Manila
      • Makati City, Manila, Philippines, 1223
        • Beverly Hills Medical Group
      • Quezon City, Manila, Philippines, 1229
        • Veterens Memorial Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed diagnosis of Type II diabetes for at least 2 years
  • Type 2 diabetics on oral hypoglycemic agents and/or insulin
  • Fasting blood sugar of >200mg% on at least two occasions
  • Willing to keep a weekly diary and undergo observation for 12 months

Exclusion Criteria:

  • Presence of of previous and/or acute diabetic complications such as myocardial infarction, CVA or nephropathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment Group
This is the only arm and that is the treatment group.
Procedure: Autologous Adipose-derived Stem cells
Intravenous administration of autologous activated stromal vascular fraction derived from 100-120 ml lipoaspirate following mini-liposuction of abdominal adipose tissue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lowering of blood glucose be it fasting, random or post prandial
Time Frame: At 2, 4, 12, 24, 36, and 48 weeks
At 2, 4, 12, 24, 36, and 48 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Decrease in anti-hyperglycemic medication dosages.
Time Frame: At 2, 4, 12, 24, 36, and 48 weeks.
At 2, 4, 12, 24, 36, and 48 weeks.
Improvement in the general well-being of patients.
Time Frame: At 2, 4, 12, 24, 36, and 48 weeks.
At 2, 4, 12, 24, 36, and 48 weeks.
Lowering of glycosylated hemoglobin (HbA1C).
Time Frame: At 4, 12, 24, 36, and 48 weeks
At 4, 12, 24, 36, and 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adistem Ltd

Investigators

  • Principal Investigator: Florencio Q Lucero, MD, University of Philippines, College of Medicine.
  • Study Chair: Bill Paspaliaris, PhD, Adistem Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (ANTICIPATED)

December 1, 2008

Study Completion (ANTICIPATED)

January 1, 2009

Study Registration Dates

First Submitted

June 19, 2008

First Submitted That Met QC Criteria

June 20, 2008

First Posted (ESTIMATE)

June 23, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 1, 2008

Last Update Submitted That Met QC Criteria

June 28, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Adis-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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