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

NCT ID: NCT01559051

Last Updated: 2017-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Obstructive Pulmonary Disease

Keywords

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COPD Pulmonary Lungs

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intravenous Injection and Inhalation infusion of AD-SVF

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

Group Type EXPERIMENTAL

Lipoaspiration with Local anesthesia

Intervention Type PROCEDURE

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

Interventions

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Lipoaspiration with Local anesthesia

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

Intervention Type PROCEDURE

Other Intervention Names

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Liposuction

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ageless Regenerative Institute

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sharon McQuillan, MD

Role: PRINCIPAL_INVESTIGATOR

Ageless Regenerative Institute

Locations

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Ageless Regenerative Institute LLC

Aventura, Florida, United States

Site Status

Countries

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Mexico United States

Other Identifiers

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AD-US-COPD-001

Identifier Type: -

Identifier Source: org_study_id