Clinical trial NCT01453751: Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered in Patients With Type II Diabetes
Official title: An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Intravenously in Patients With Type II Diabetes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetes Mellitus Type II
Keywords: Diabetes
Type 2 Diabetes
Lead sponsor: Ageless Regenerative Institute
Sponsor class: INDUSTRY
First posted: 2011-10-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Reduction of insulin requirement by > 50%
timeFrame: 3 months and 6 months
measure: Number of adverse events reported
timeFrame: up to the 6-month period following treatment
Secondary outcomes:
measure: Improvement of Hemoglobin A1c(HbA1c) levels as compared to baseline
timeFrame: 3 months and 6 months
measure: reduction in requirement of insulin dosage compared to baseline
timeFrame: 3 months
Other outcomes:
Locations:
city: Aventura
country: United States
facility: Ageless Regenerative Institute LLC
state: Florida
Study officials:
affiliation: Ageless Regenerative Institute
name: Sharon McQuillan, MD
role: PRINCIPAL_INVESTIGATOR
References: