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WithdrawnNCT01453751Updated Nov 24, 2017

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

An interventional study of Harvesting and Implantation of Adipose-Derived Stromal Vascular Fraction (AD-SVF) in Diabetes Mellitus Type II, sponsored by Ageless Regenerative Institute. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-11-24.

Sponsored by Ageless Regenerative Institute · Not applicable, Interventional, and Treatment

Why this study was withdrawn
company dissolved
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus Type II

Keywords

  • Diabetes
  • Type 2 Diabetes
03

In context

Diabetes Mellitus, Type 2

9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Ageless Regenerative Institute is the lead sponsor of 17 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Intravenous Injection of AD-SVF

    Intravenous administration of AD-SVF.

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

Interventions

  • ProcedureHarvesting 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.

    Also known as: Lipoaspiration, Liposuction

06

What researchers measure

Primary outcomes

  1. Reduction of insulin requirement by > 50%

    Time frame: 3 months and 6 months

  2. 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.

    Time frame: up to the 6-month period following treatment

Secondary outcomes

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

    Blood sample

    Time frame: 3 months and 6 months

  2. reduction in requirement of insulin dosage compared to baseline

    Time frame: 3 months

07

Study locations

1 site
  • Ageless Regenerative Institute LLC
    Aventura, Florida 33180, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2014, a primary completion of Nov 2017 and a completion of Dec 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 3, 2011
First posted
Oct 18, 2011
Start
Mar 2014
Primary completionEst.
Nov 2017
CompletionEst.
Dec 2017
Last update
Nov 24, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01453751
Lead sponsor
Ageless Regenerative Institute
Responsible party
Sponsor
First posted
Oct 18, 2011
Start date
Mar 2014
Primary completion
Nov 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Nov 24, 2017

Study contacts

Sharon McQuillan, MD
principal investigator · Ageless Regenerative Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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