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

Withdrawn before enrolling · Not applicable

Conditions studied: Diabetes Mellitus Type II

In brief

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.

Key facts

Study ID

NCT01453751

Run by

Ageless Regenerative Institute

People needed

0

Starts

2014-03-01

Expected to finish

2017-12-01

Last updated by the study team

2017-11-24

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Ageless Regenerative Institute LLC — Aventura, Florida, United States

Full record on ClinicalTrials.gov

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