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

Diabetes Mellitus Type II Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01453751
• Other study ID #: AD-US-DM2-001
• Status: Withdrawn
• Phase: N/A
• First received: October 3, 2011
• Last updated: November 21, 2017
• Start date: March 2014
• Est. completion date: December 2017

Study information

• Verified date: November 2017
• Source: Ageless Regenerative Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type II
• Diabetes Mellitus, Type 2

Intervention

Procedure:
• Harvesting and Implantation of Adipose-Derived Stromal Vascular Fraction (AD-SVF)
ASCs will be derived from the patient's adipose-derived tissue. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells.

Locations

Country	Name	City	State
United States	Ageless Regenerative Institute LLC	Aventura	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Ageless Regenerative Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of insulin requirement by > 50%		3 months and 6 months
Primary	Number of adverse events reported	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.	up to the 6-month period following treatment
Secondary	Improvement of Hemoglobin A1c(HbA1c) levels as compared to baseline	Blood sample	3 months and 6 months
Secondary	reduction in requirement of insulin dosage compared to baseline		3 months