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

This study is currently recruiting participants.
Verified March 2014 by Ageless Regenerative Institute
Sponsor:
Information provided by (Responsible Party):
Ageless Regenerative Institute
ClinicalTrials.gov Identifier:
NCT01453751
First received: October 3, 2011
Last updated: March 19, 2014
Last verified: March 2014

October 3, 2011
March 19, 2014
March 2014
April 2016   (final data collection date for primary outcome measure)
  • Reduction of insulin requirement by > 50% [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]
  • Number of adverse events reported [ Time Frame: up to the 6-month period following treatment ] [ Designated as safety issue: No ]
    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.
  • Reduction of insulin requirement by > 50% [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • safety of adipose-derived stem cell injection [ Time Frame: up to the 6-month period following treatment ] [ Designated as safety issue: Yes ]
    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.
  • Reduction of insulin requirement by > 50% [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    Autologous ASCs therapy will be considered effective for type II diabetes patients if:

    - Reduction of insulin requirement by > 50% by the end of 6 months.

Complete list of historical versions of study NCT01453751 on ClinicalTrials.gov Archive Site
  • Improvement of Hemoglobin A1c(HbA1c) levels as compared to baseline [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]
    Blood sample
  • reduction in requirement of insulin dosage compared to baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • reduction in requirement of insulin dosage [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Improvement of Hemoglobin A1c(HbA1c) levels as compared to baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Improvement of HbA1c levels as compared to baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • reduction in requirement of insulin dosage compared to baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered in Patients With Type II Diabetes
An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Via Catheter Into the Pancreatic Artery and/or Intravenously in Patients With Type II Diabetes

This will be an open-label, non-randomized, multi-center, patient sponsored study of Adipose-Derived Stem Cell (ASC) implantation via intravenous push 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.

ASCs will be collected from the patient's adipose-derived tissue (body fat). Using local anesthesia, Liposuction will be performed to collect the adipose tissue specimen. The adipose tissue is then transferred to the laboratory for separation of the adipose tissue derived stem cells. In addition, peripheral blood will be collected for isolation of platelet rich plasma, which are then combined with the ASC's for intravenous push administration.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus Type II
Procedure: Harvesting and Implantation of Adipose-Derived Stem Cells (ASCs)
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. The second arm consists of an IV push only with ASCs
Experimental: Intravenous Injection Only
Intravenous administration of the ASCs only.
Intervention: Procedure: Harvesting and Implantation of Adipose-Derived Stem Cells (ASCs)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
December 2016
April 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact: Melissa Mayans 954-707-5080 ext 3334 clinicaltrials@agelessinstitute.com
United States
 
NCT01453751
ADI-DI-US-001
No
Ageless Regenerative Institute
Ageless Regenerative Institute
Not Provided
Principal Investigator: Sharon McQuillan, MD Ageless Regenerative Institute
Ageless Regenerative Institute
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP