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

Primary Purpose

Diabetes Mellitus Type II

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Harvesting and Implantation of Adipose-Derived Stromal Vascular Fraction (AD-SVF)
Sponsored by
Ageless Regenerative Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type II focused on measuring Diabetes, Type 2 Diabetes

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ageless Regenerative Institute LLC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intravenous Injection of AD-SVF

Arm Description

Intravenous administration of AD-SVF.

Outcomes

Primary Outcome Measures

Reduction of insulin requirement by > 50%
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.

Secondary Outcome Measures

Improvement of Hemoglobin A1c(HbA1c) levels as compared to baseline
Blood sample
reduction in requirement of insulin dosage compared to baseline

Full Information

First Posted
October 3, 2011
Last Updated
November 21, 2017
Sponsor
Ageless Regenerative Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01453751
Brief Title
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

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Withdrawn
Why Stopped
company dissolved
Study Start Date
March 2014 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ageless Regenerative Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type II
Keywords
Diabetes, Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravenous Injection of AD-SVF
Arm Type
Experimental
Arm Description
Intravenous administration of AD-SVF.
Intervention Type
Procedure
Intervention Name(s)
Harvesting and Implantation of Adipose-Derived Stromal Vascular Fraction (AD-SVF)
Other Intervention Name(s)
Lipoaspiration, Liposuction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction of insulin requirement by > 50%
Time Frame
3 months and 6 months
Title
Number of adverse events reported
Description
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.
Time Frame
up to the 6-month period following treatment
Secondary Outcome Measure Information:
Title
Improvement of Hemoglobin A1c(HbA1c) levels as compared to baseline
Description
Blood sample
Time Frame
3 months and 6 months
Title
reduction in requirement of insulin dosage compared to baseline
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon McQuillan, MD
Organizational Affiliation
Ageless Regenerative Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ageless Regenerative Institute LLC
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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