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

A

Ageless Regenerative Institute

Status

Withdrawn

Conditions

Diabetes Mellitus Type II

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT01453751
AD-US-DM2-001

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 80 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Intravenous Injection of AD-SVF
Experimental group
Description:
Intravenous administration of AD-SVF.
Treatment:
Procedure: Harvesting and Implantation of Adipose-Derived Stromal Vascular Fraction (AD-SVF)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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