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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Ageless Regenerative Institute
Sponsor:
Information provided by (Responsible Party):
Ageless Regenerative Institute
ClinicalTrials.gov Identifier:
NCT01453751
First received: October 3, 2011
Last updated: April 6, 2016
Last verified: April 2016
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus Type II
Procedure: Harvesting and Implantation of Adipose-Derived Stromal Vascular Fraction (AD-SVF)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Ageless Regenerative Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: March 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intravenous Injection of AD-SVF
Intravenous administration of AD-SVF.
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.
Other Names:
  • Lipoaspiration
  • Liposuction

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01453751

Contacts
Contact: Marcela Salgado, MD 954-7447400 ext 4455 clinicaltrials@agelessinstitute.com
Contact: Noelle Smith, Manager 305-9332988 nsmith@agelessinstitute.com

Locations
United States, Florida
Ageless Regenerative Institute LLC Recruiting
Aventura, Florida, United States, 33180
Contact: Marcela Salgado, MD    954-744-7400 ext 4455    clinicaltrials@agelessinstitute.com   
Contact: Noelle Smith, Manager    305-9332988    nsmith@agelessinstitute.com   
Principal Investigator: Sharon McQuillan, MD         
Ageless Institute Recruiting
Miami, Florida, United States, 33180
Contact: Melissa Mayans    305-933-2988    clinicaltrials@agelessinstitute.com   
Sponsors and Collaborators
Ageless Regenerative Institute
Investigators
Principal Investigator: Sharon McQuillan, MD Ageless Regenerative Institute
  More Information

Responsible Party: Ageless Regenerative Institute
ClinicalTrials.gov Identifier: NCT01453751     History of Changes
Other Study ID Numbers: AD-US-DM2-001 
Study First Received: October 3, 2011
Last Updated: April 6, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Ageless Regenerative Institute:
Diabetes
Type 2 Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 21, 2016