Use of Autologous, Adult Adipose-Derived Stem/Stromal Cells In Chronic Lung Disorders (ADcSVF-COPD)

February 26, 2024 updated by: Robert W. Alexander, MD, FICS, Healeon Medical Inc

Use of Autologous, Adult Adipose-Derived Stem/Stromal Cells (AD-cSVF) in Chronic Lung Disorders

Chronic Obstructive Pulmonary Disease (COPD) is a lung-related disorder that is characterized by long-term, often progressive state of poor airflow. Primary symptoms include low oxygen tension, shortness of breath, productive cough, and broncho-pulmonary inflammation and interference with oxygen-carbon dioxide exchange.

Air pollution and tobacco smoking are felt to be the most common cause of these issues. Diagnostic testing is based on poor airflow measured by lung function studies and whose symptoms do not improve much with antiasthma bronchodilators.

Study is an interventional study to document the safety and efficacy of use of AD-cSVF in chronic broncho-pulmonary disease groups.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

COPD is often treated by limiting exposure to poor air quality, but there is no cure at this time. Attempted therapy include smoking cessation, vaccinations, respiratory rehabilitation, and attempts of use of bronchodilators and steroids. Many resort to supplemental oxygen therapy, lung transplantation, and antibiotic supportive therapy during exacerbations.

As of 2013, COPD involve approximately 5% pf the global populations (approximately 330 million). Most commonly it occurs approximately equally between men/women and result in about 3 million deaths per year. Estimates of economic costs are estimated to be more than 2.1 trillion dollars in 2010.

This study includes microcannula harvesting of subdermal adipose tissues, incubation, digestion and isolation of AD-cSVF. This stromal cellular pellet (without actual extracellular matrix or stromal elements) is then suspended in 500 cc sterile Normal Saline (NS) and deployed via peripheral intravenous route. Evaluations of safety issues are measured at intervals (both severe and non-severe categories) and by repeated pulmonary function studies.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Honduras
    • HN
      • Roatan, HN, Honduras
        • Global Alliance for Regenerative Medicine (GARM)
  • United States
    • Montana
      • Stevensville, Montana, United States, 59870
        • Regenevita LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Prior Diagnosis of moderate to severe COPD
  • GOLD II a, III, IV

Exclusion Criteria:

  • Pregnant or Lactating Females
  • Life expectancy of < 3 months due to concomitant illnesses
  • Exposure to any investigational drug or procedure with 1 month prior to study entry or enrollment in concurrent study which may interfere with interpretation of study results
  • Illness which, in investigators judgement, may interfere with the patient' ability to comply with protocol, compromise patient safety, ability to provide informed consent to study, or interfere with interpretation of study outcomes
  • Subjects on chronic immunosuppressive or chemotherapeutic medications
  • Known drug or alcohol dependence or other factors which may interfere with study conduct or interpretation of result or in the opinion of investigator are not suitable to participate.
  • Subjects with documented Alpha-1 Antitrypsin Deficiency (Inherited lung and liver disorder)
  • Unwilling or not competent to understand and execute an informed consent agreement
  • Patients positive for Hepatitis (Hepatitis A history excepted)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Normal Saline IV Arm 3
Normal Saline IV with AD-cSVF cells
Procedure: Normal Saline IV
Normal Saline IV containing AD-cSVF
Experimental: Lipoaspiration Arm 1
Acquisition of Adipose-Derived tissue Stromal Vascular Fraction (AD-tSVF) via closed syringe harvest subdermal fat
Procedure: lipoaspiration
Closed syringe harvesting subdermal fat
Experimental: AD-cSVF Arm 2
Isolation of cellular stem/stromal cells from subdermal adipose-derived cellular stromal vascular fraction (AD-cSVF)
Procedure: ADcSVF
Isolation of AD-cSVF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety - Pulmonary Function
Time Frame: 12 months Evaluate Function and Adverse Events
Pulmonary Function to be Addressed as occurrence or frequency of adverse event during study
12 months Evaluate Function and Adverse Events

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Respiratory Rate
Time Frame: 1 month, 6 month, 1 year
Measured rate clinically at rest
1 month, 6 month, 1 year
GOLD Classification
Time Frame: 1 year
Global Initiative for Chronic Obstructive Lung Disease (GOLD) is a COPD staging system based on degree of airflow limitations (obstruction) and measured by pulmonary function studies
1 year
Change from baseline 6 Minute Walk Test
Time Frame: 12 Months
Exercise capacity measured by distance a patient can walk in 6 minute timeframe
12 Months
Change from Baseline Lung X-Ray
Time Frame: 6 months, 12 months
standard flat film x-ray
6 months, 12 months
Change from Baseline SGOT Blood Testing
Time Frame: 1 Month
Measure Blood Serum Glutamate Oxaloacetate Transaminase (SGOT) Measure Blood Elevation with liver damage
1 Month
Change from Baseline SGPT Blood Testing
Time Frame: 1 Month
Measure Blood Serum Glutamate Pyruvate Transaminase (SGPT) elevation with liver damage
1 Month
Pulmonary Function Testing
Time Frame: Baseline, 6 Months
Measure Baseline Pulmonary Function (FEV/FEVi Measure)
Baseline, 6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Healeon Medical Inc

Collaborators

Terry, Glenn C., M.D.

Investigators

  • Principal Investigator: Glenn C. Terry, MD, Global Alliance for Regenerative Medicine (GARM)
  • Principal Investigator: Robert W Alexander, MD, Healeon Medical Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Estimated)

August 14, 2025

Study Completion (Estimated)

August 14, 2025

Study Registration Dates

First Submitted

October 3, 2016

First Submitted That Met QC Criteria

October 25, 2016

First Posted (Estimated)

October 27, 2016

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGV-GARM 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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