NCT01453751

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 18, 2011

Completed
2.4 years until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 24, 2017

Status Verified

November 1, 2017

Enrollment Period

3.7 years

First QC Date

October 3, 2011

Last Update Submit

November 21, 2017

Conditions

Diabetes Mellitus Type II

Keywords

DiabetesType 2 Diabetes

Outcome Measures

Primary Outcomes (2)

  • Reduction of insulin requirement by > 50%

    3 months and 6 months

  • 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 Outcomes (2)

  • Improvement of Hemoglobin A1c(HbA1c) levels as compared to baseline

    3 months and 6 months

  • reduction in requirement of insulin dosage compared to baseline

    3 months

Study Arms (1)

Intravenous Injection of AD-SVF

EXPERIMENTAL

Intravenous administration of AD-SVF.

Procedure: Harvesting and Implantation of Adipose-Derived Stromal Vascular Fraction (AD-SVF)

Interventions

Harvesting and Implantation of Adipose-Derived Stromal Vascular Fraction (AD-SVF)PROCEDURE

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.

Also known as: Lipoaspiration, Liposuction
Intravenous Injection of AD-SVF

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ageless Regenerative Institute LLC

Aventura, Florida, 33180, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Lipectomy

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Cosmetic TechniquesTherapeuticsBariatric SurgeryBariatricsObesity ManagementSurgical Procedures, OperativePlastic Surgery Procedures

Study Officials

  • Sharon McQuillan, MD

    Ageless Regenerative Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2011

First Posted

October 18, 2011

Study Start

March 1, 2014

Primary Completion

November 1, 2017

Study Completion

December 1, 2017

Last Updated

November 24, 2017

Record last verified: 2017-11

Locations

US(1)