Status:
WITHDRAWN
Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered in Patients With Type II Diabetes
Lead Sponsor:
Ageless Regenerative Institute
Conditions:
Diabetes Mellitus Type II
Eligibility:
All Genders
18-80 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01453751
Start Date
March 1 2014
End Date
December 1 2017
Last Update
November 24 2017
Active Locations (1)
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1
Ageless Regenerative Institute LLC
Aventura, Florida, United States, 33180