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

NCT ID: NCT00703612

Last Updated: 2008-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus

Keywords

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Diabetes Mellitus Adipose-derived stem cells Adipose stromal vascular fraction Autologous Hyperglycemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Group

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Group Type EXPERIMENTAL

Autologous Adipose-derived Stem cells

Intervention Type PROCEDURE

Intravenous administration of autologous activated stromal vascular fraction derived from 100-120 ml lipoaspirate following mini-liposuction of abdominal adipose tissue.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Adistem Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Adistem Ltd

Principal Investigators

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Emeritta A Barrenechea, MD

Role: PRINCIPAL_INVESTIGATOR

Veterens Memorial Medical Centre, Philippines

Florencio Q Lucero, MD

Role: PRINCIPAL_INVESTIGATOR

University of Philippines, College of Medicine.

Letitia Lucero-Palma, MD

Role: STUDY_DIRECTOR

Far Eastern University-NRMF Hospital, Quezon City, Philippines

Bill Paspaliaris, PhD

Role: STUDY_CHAIR

Adistem Ltd

Locations

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Beverly Hills Medical Group

Makati City, Manila, Philippines

Site Status

Veterens Memorial Medical Centre

Quezon City, Manila, Philippines

Site Status

Countries

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Philippines

References

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Gimble JM, Katz AJ, Bunnell BA. Adipose-derived stem cells for regenerative medicine. Circ Res. 2007 May 11;100(9):1249-60. doi: 10.1161/01.RES.0000265074.83288.09.

Reference Type BACKGROUND
PMID: 17495232 (View on PubMed)

Other Identifiers

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Adis-002

Identifier Type: -

Identifier Source: org_study_id