Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered in Patients With Type II Diabetes

NCT ID: NCT01453751

Last Updated: 2017-11-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2017-12-31

Brief Summary

This will be an open-label, non-randomized, multi-center, patient sponsored study of Adipose-Derived Stromal vascular fraction cells implantation via intravenous infusion.

The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the disease pathology of patients with diagnosed Type II Diabetes Mellitus.

Conditions

Diabetes Mellitus Type II

Keywords

Diabetes; Type 2 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intravenous Injection of AD-SVF

Intravenous administration of AD-SVF.

Group Type: EXPERIMENTAL

Harvesting and Implantation of Adipose-Derived Stromal Vascular Fraction (AD-SVF)

Intervention Type: PROCEDURE

ASCs will be derived from the patient's adipose-derived tissue. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells.

Interventions

Harvesting and Implantation of Adipose-Derived Stromal Vascular Fraction (AD-SVF)

ASCs will be derived from the patient's adipose-derived tissue. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells.

Intervention Type: PROCEDURE

Other Intervention Names

Lipoaspiration; Liposuction

Eligibility Criteria

Inclusion Criteria

• Males and Females between Age 18 and 80 years.
• Type 2 diabetes mellitus (as guideline WHO, 1999);
• Body mass index (BMI)≤35㎏/㎡;
• Fast blood glucose (FBG)≥7.0 mmol/L, and Hemoglobin A1c (HgbA1c)≥7％;
• Up to date on all age and gender appropriate cancer screening per American Cancer Society.

Exclusion Criteria

• Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
• Life expectancy < 6 months due to concomitant illnesses.
• Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
• Active infectious disease. If patients have tested positive, they will be consulted as to patient eligibility based on the patient's infectious status
• Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
• Patients on chronic immunosuppressive transplant therapy
• Systolic blood pressure (supine) ≤90 mmHg or >180mmHg
• Resting heart rate > 100 bpm;
• Active clinical infection within one week of enrollment.
• Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
• History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
• Unwilling and/or not able to give written informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ageless Regenerative Institute

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sharon McQuillan, MD

Role: PRINCIPAL_INVESTIGATOR

Ageless Regenerative Institute

Locations

Ageless Regenerative Institute LLC

Aventura, Florida, United States

Countries

Mexico; United States

Other Identifiers

AD-US-DM2-001

Identifier Type: -

Identifier Source: org_study_id