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WithdrawnNCT01559051Updated Nov 24, 2017

Safety and Efficacy of Adipose Derived Stem Cells for Chronic Obstructive Pulmonary Disease

A Phase 1/2 interventional study of Lipoaspiration with Local anesthesia in Chronic Obstructive Pulmonary Disease, 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 Withdrawn at 1 site in United States.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 · Phase 1/2, Interventional, and Treatment

Why this study was withdrawn
company dissolved
Phase
Phase 1/2
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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 health of patients with human Chronic Obstructive Pulmonary Disease.

Read the detailed description

This will be an open-label, non-randomized multi-center patient sponsored study of Autologous SVF (AD-SVF) implantation after liposuction using an IV delivery system and Inhalation infusion. AD-SVF 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 cells will be delivered intravenously.

The adipose tissue specimen will be collected from the patient's abdomen or applicable area using tumescent syringe liposuction. The adipose tissue is transferred to the laboratory for separation of the adipose tissue-derived stem cells, which are then transferred for IV delivery. The number of cells injected will vary depending on the amount of tissue processed and the number of cells obtained from the process.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease

Keywords

  • COPD
  • Pulmonary
  • Lungs
03

In context

Pulmonary Disease, Chronic Obstructive

4,252 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.

Browse Pulmonary Disease, Chronic Obstructive 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

  • A prior diagnosis of moderate or severe COPD
  • GOLD III and IV
  • Age between 25 and 80 years
  • 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 patients known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis. will have an expert 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
  • 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.
  • Severe asthma that would contraindicate surgery
  • 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
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Intravenous Injection and Inhalation infusion of AD-SVF

    AD-SVF harvested from Autologous Adipose Tissue will be deliver after processing via IV and Inhalation

    Procedure: Lipoaspiration with Local anesthesia

Interventions

  • ProcedureLipoaspiration with Local anesthesia

    Patients undergo a liposuction under local Anethesia. The AD-SVF are then isolated and infused IV and by inhalation delivery.

    Also known as: Liposuction

06

What researchers measure

Primary outcomes

  1. Functional Capacity improved compared to baseline

    6 Minute Walk Test

    Time frame: 3 months, 6 months

  2. Number of adverse events

    Time frame: 3 months, 6 months

Secondary outcomes

  1. Quality of Life improved compared to baseline

    St. George Respiratory Questionnaire

    Time frame: 3 months, 6 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
Mar 19, 2012
First posted
Mar 21, 2012
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
NCT01559051
Lead sponsor
Ageless Regenerative Institute
Responsible party
Sponsor
First posted
Mar 21, 2012
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 Sep 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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