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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00703612
• Other study ID #: Adis-002
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: June 19, 2008
• Last updated: June 28, 2008
• Start date: November 2007
• Est. completion date: January 2009

Study information

• Verified date: June 2008
• Source: Adistem Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Department of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 34
• Est. completion date: January 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
Philippines	Beverly Hills Medical Group	Makati City	Manila
Philippines	Veterens Memorial Medical Centre	Quezon City	Manila

Sponsors (1)

Lead Sponsor	Collaborator
Adistem Ltd

Country where clinical trial is conducted

Philippines, 

References & Publications (1)

Gimble JM, Katz AJ, Bunnell BA. Adipose-derived stem cells for regenerative medicine. Circ Res. 2007 May 11;100(9):1249-60. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lowering of blood glucose be it fasting, random or post prandial		At 2, 4, 12, 24, 36, and 48 weeks	Yes
Secondary	Decrease in anti-hyperglycemic medication dosages.		At 2, 4, 12, 24, 36, and 48 weeks.	Yes
Secondary	Improvement in the general well-being of patients.		At 2, 4, 12, 24, 36, and 48 weeks.	Yes
Secondary	Lowering of glycosylated hemoglobin (HbA1C).		At 4, 12, 24, 36, and 48 weeks	Yes

External Links

•   NIH website describing basic facts on adult stem cells