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

Primary Purpose

Type 1 Diabetes Mellitus

Status

Unknown status

Phase

Phase 1

Locations

Philippines

Study Type

Interventional

Intervention

Autologous Adipose-derived Stem cells

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Diabetes Mellitus, Adipose-derived stem cells, Adipose stromal vascular fraction, Autologous, Insulin-dependence

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Beverly Hills Medical GroupRecruiting
Veterens Memorial Medical CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

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

Outcomes

Primary Outcome Measures

Lowering of insulin-dependence and anti-hyperglycemic medication dosages

Secondary Outcome Measures

Lowering of glycosylated hemoglobin (HbA1C).

Increased circulating C-Peptide levels

Increased general well-being of patients.

No detrimental change seen in kidney function tests, liver function tests and other haematological parameters.

Full Information

NCT ID

NCT00703599

First Posted

June 19, 2008

Last Updated

June 28, 2008

Sponsor

Adistem Ltd

1. Study Identification

Unique Protocol Identification Number

NCT00703599

Brief Title

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

Official Title

Phase I/II Study of Intravenous Administration of Activated Autologous Adipose-Derived Stromal Vascular Fraction in Patients With Type 1 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

June 2008

Overall Recruitment Status

Unknown status

Study Start Date

November 2007 (undefined)

Primary Completion Date

November 2009 (Anticipated)

Study Completion Date

December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Adistem Ltd

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes Mellitus

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Autologous Adipose-derived Stem cells

Other Intervention Name(s)

Treatment Group

Intervention Description

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

Primary Outcome Measure Information:

Title

Lowering of insulin-dependence and anti-hyperglycemic medication dosages

Time Frame

At 2, 4, 12, 24, 36, and 48 weeks

Secondary Outcome Measure Information:

Title

Lowering of glycosylated hemoglobin (HbA1C).

Time Frame

At 4, 12, 24, 36, and 48 weeks

Title

Increased circulating C-Peptide levels

Time Frame

At 4, 12, 24, 36, and 48 weeks.

Title

Increased general well-being of patients.

Time Frame

At 2, 4, 12, 24, 36, and 48 weeks.

Title

No detrimental change seen in kidney function tests, liver function tests and other haematological parameters.

Time Frame

At 2, 4, 12, 24, 36, and 48 weeks.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Letitia Lucero-Palma, MD

Phone

63-916-478-7512

lettielucero@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Emeritta A Barrenechea, MD

Organizational Affiliation

Veterens Memorial Medical Centre, Philippines

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Florencio Q Lucero, MD

Organizational Affiliation

University of Philippines, College of Medicine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Letitia Lucero-Palma, MD

Organizational Affiliation

Far Eastern University-NRMF Hospital, Quezon City, Philippines

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Bill Paspaliaris, PhD

Organizational Affiliation

Adistem Ltd, Hong Kong

Official's Role

Study Chair

Facility Information:

Facility Name

Beverly Hills Medical Group

City

Makati City

State/Province

Manila

Country

Philippines

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Florencio Q Lucero, MD

Phone

63-917-896-6411

dr-flucero@pldtdsl.net

First Name & Middle Initial & Last Name & Degree

Florencio Q Lucero, MD

Facility Name

Veterens Memorial Medical Centre

City

Quezon City

State/Province

Manila

ZIP/Postal Code

1229

Country

Philippines

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Emerita A Barrenechea, MD

Phone

63-917-811-1008

emieab@yahoo.com

First Name & Middle Initial & Last Name & Degree

Emerita A Barrenechea, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

17495232

Citation

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.

Results Reference

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

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