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

Not Applicable

Withdrawn

• Conditions: Diabetes Mellitus Type II
• Interventions: Procedure: Harvesting and Implantation of Adipose-Derived Stromal Vascular Fraction (AD-SVF)

• Registration Number: NCT01453751
• Lead Sponsor: Ageless Regenerative Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-03
• Study First Submitted QC: 2011-10-17
• Study First Posted: 2011-10-18
• Study Start: 2014-03
• Status Verified: 2017-11
• Primary Completion: 2017-11
• Last Update Submitted: 2017-11-21
• Last Update Posted: 2017-11-24
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intravenous Injection of AD-SVF	Harvesting and Implantation of Adipose-Derived Stromal Vascular Fraction (AD-SVF)	Intravenous administration of AD-SVF.

Primary Outcome Measures

Name	Time	Method
Reduction of insulin requirement by > 50%	3 months and 6 months
Number of adverse events reported	up to the 6-month period following treatment	The safety of adipose-derived stem cell injection will be evaluated by assessment of the frequency and nature of adverse events occurring during the study injection and up to the 6-month period following treatment.

Secondary Outcome Measures

Name	Time	Method
Improvement of Hemoglobin A1c(HbA1c) levels as compared to baseline	3 months and 6 months	Blood sample
reduction in requirement of insulin dosage compared to baseline	3 months

Trial Locations

Locations (1)

Ageless Regenerative Institute LLC; 🇺🇸 Aventura, Florida, United States