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

Ageless Regenerative Institute

Status

Withdrawn

Conditions

Diabetes Mellitus Type II

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT01453751

AD-US-DM2-001

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.