Safety and Efficacy of Autologous Adipose-Derived Stem Cell Transplantation in Patients With Type 1 Diabetes

NCT ID: NCT00703599

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-12-31

Brief Summary

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The purpose of this study is to determine whether intravenous administration of autologous adipose stem cells is safe and beneficial in patients with type 1 diabetes.

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 I/II study is to determine whether the intravenous administration of activated adipose-derived stromal vascular fraction as a single procedure is safe and efficacious in patients with Type 1 Diabetes Mellitus. Patients will be observed over 12 months following the procedure, with 2 weeks, 1 month and tri-monthly diagnostics and life style questionaires.

Conditions

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Type 1 Diabetes Mellitus

Keywords

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Diabetes Mellitus Adipose-derived stem cells Adipose stromal vascular fraction Autologous Insulin-dependence

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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1

This is the only arm and that is the treatment group.

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

Other Intervention Names

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Treatment Group

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of Type I diabetes for at least 2 years
* Insulin-dependent

Exclusion Criteria

* Presence of acute diabetic complications in the acute stage as recent myocardial infarction, recent CVA or acute renal failure.
Minimum Eligible Age

16 Years

Maximum Eligible Age

60 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, Hong Kong

Locations

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Beverly Hills Medical Group

Makati City, Manila, Philippines

Site Status RECRUITING

Veterens Memorial Medical Centre

Quezon City, Manila, Philippines

Site Status RECRUITING

Countries

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Philippines

Central Contacts

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Letitia Lucero-Palma, MD

Role: CONTACT

Phone: 63-916-478-7512

Email: [email protected]

Facility Contacts

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Florencio Q Lucero, MD

Role: primary

Emerita A Barrenechea, MD

Role: primary

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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Ad-003

Identifier Type: -

Identifier Source: org_study_id