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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02946658
Recruitment Status : Enrolling by invitation
First Posted : October 27, 2016
Last Update Posted : August 3, 2022
Terry, Glenn C., M.D.
Information provided by (Responsible Party):
Robert W. Alexander, MD, FICS, Healeon Medical Inc

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Lung Disease Procedure: lipoaspiration Procedure: ADcSVF Procedure: Normal Saline IV Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Use of Autologous, Adult Adipose-Derived Stem/Stromal Cells (AD-cSVF) in Chronic Lung Disorders
Actual Study Start Date : October 2016
Estimated Primary Completion Date : August 14, 2024
Estimated Study Completion Date : August 14, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases

Arm Intervention/treatment
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

Experimental: Normal Saline IV Arm 3
Normal Saline IV with AD-cSVF cells
Procedure: Normal Saline IV
Normal Saline IV containing AD-cSVF

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Change from Baseline Respiratory Rate [ Time Frame: 1 month, 6 month, 1 year ]
    Measured rate clinically at rest

  2. 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

  3. Change from baseline 6 Minute Walk Test [ Time Frame: 12 Months ]
    Exercise capacity measured by distance a patient can walk in 6 minute timeframe

  4. Change from Baseline Lung X-Ray [ Time Frame: 6 months, 12 months ]
    standard flat film x-ray

  5. Change from Baseline SGOT Blood Testing [ Time Frame: 1 Month ]
    Measure Blood Serum Glutamate Oxaloacetate Transaminase (SGOT) Measure Blood Elevation with liver damage

  6. Change from Baseline SGPT Blood Testing [ Time Frame: 1 Month ]
    Measure Blood Serum Glutamate Pyruvate Transaminase (SGPT) elevation with liver damage

  7. Pulmonary Function Testing [ Time Frame: Baseline, 6 Months ]
    Measure Baseline Pulmonary Function (FEV/FEVi Measure)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02946658

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United States, Montana
Regenevita LLC
Stevensville, Montana, United States, 59870
Global Alliance for Regenerative Medicine (GARM)
Roatan, HN, Honduras
Sponsors and Collaborators
Healeon Medical Inc
Terry, Glenn C., M.D.
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Principal Investigator: Robert W Alexander, MD Healeon Medical Inc
Principal Investigator: Glenn C. Terry, MD Global Alliance for Regenerative Medicine (GARM)
Publications of Results:

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Responsible Party: Robert W. Alexander, MD, FICS, Principal Investigator, Science, Healeon Medical Inc
ClinicalTrials.gov Identifier: NCT02946658    
Other Study ID Numbers: RGV-GARM 2
First Posted: October 27, 2016    Key Record Dates
Last Update Posted: August 3, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robert W. Alexander, MD, FICS, Healeon Medical Inc:
COPD, Emphysema
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases