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

Primary Purpose

Lung Disease

Status
Enrolling by invitation
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
lipoaspiration
ADcSVF
Normal Saline IV
Sponsored by
Healeon Medical Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Disease focused on measuring COPD, Emphysema

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Regenevita LLC
  • Global Alliance for Regenerative Medicine (GARM)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Lipoaspiration Arm 1

AD-cSVF Arm 2

Normal Saline IV Arm 3

Arm Description

Acquisition of Adipose-Derived tissue Stromal Vascular Fraction (AD-tSVF) via closed syringe harvest subdermal fat

Isolation of cellular stem/stromal cells from subdermal adipose-derived cellular stromal vascular fraction (AD-cSVF)

Normal Saline IV with AD-cSVF cells

Outcomes

Primary Outcome Measures

Safety - Pulmonary Function
Pulmonary Function to be Addressed as occurrence or frequency of adverse event during study

Secondary Outcome Measures

Change from Baseline Respiratory Rate
Measured rate clinically at rest
GOLD Classification
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
Change from baseline 6 Minute Walk Test
Exercise capacity measured by distance a patient can walk in 6 minute timeframe
Change from Baseline Lung X-Ray
standard flat film x-ray
Change from Baseline SGOT Blood Testing
Measure Blood Serum Glutamate Oxaloacetate Transaminase (SGOT) Measure Blood Elevation with liver damage
Change from Baseline SGPT Blood Testing
Measure Blood Serum Glutamate Pyruvate Transaminase (SGPT) elevation with liver damage
Pulmonary Function Testing
Measure Baseline Pulmonary Function (FEV/FEVi Measure)

Full Information

First Posted
October 3, 2016
Last Updated
August 1, 2022
Sponsor
Healeon Medical Inc
Collaborators
Terry, Glenn C., M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT02946658
Brief Title
Use of Autologous, Adult Adipose-Derived Stem/Stromal Cells In Chronic Lung Disorders
Acronym
ADcSVF-COPD
Official Title
Use of Autologous, Adult Adipose-Derived Stem/Stromal Cells (AD-cSVF) in Chronic Lung Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 2016 (Actual)
Primary Completion Date
August 14, 2024 (Anticipated)
Study Completion Date
August 14, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Healeon Medical Inc
Collaborators
Terry, Glenn C., M.D.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Disease
Keywords
COPD, Emphysema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lipoaspiration Arm 1
Arm Type
Experimental
Arm Description
Acquisition of Adipose-Derived tissue Stromal Vascular Fraction (AD-tSVF) via closed syringe harvest subdermal fat
Arm Title
AD-cSVF Arm 2
Arm Type
Experimental
Arm Description
Isolation of cellular stem/stromal cells from subdermal adipose-derived cellular stromal vascular fraction (AD-cSVF)
Arm Title
Normal Saline IV Arm 3
Arm Type
Experimental
Arm Description
Normal Saline IV with AD-cSVF cells
Intervention Type
Procedure
Intervention Name(s)
lipoaspiration
Intervention Description
Closed syringe harvesting subdermal fat
Intervention Type
Procedure
Intervention Name(s)
ADcSVF
Intervention Description
Isolation of AD-cSVF
Intervention Type
Procedure
Intervention Name(s)
Normal Saline IV
Intervention Description
Normal Saline IV containing AD-cSVF
Primary Outcome Measure Information:
Title
Safety - Pulmonary Function
Description
Pulmonary Function to be Addressed as occurrence or frequency of adverse event during study
Time Frame
12 months Evaluate Function and Adverse Events
Secondary Outcome Measure Information:
Title
Change from Baseline Respiratory Rate
Description
Measured rate clinically at rest
Time Frame
1 month, 6 month, 1 year
Title
GOLD Classification
Description
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
Time Frame
1 year
Title
Change from baseline 6 Minute Walk Test
Description
Exercise capacity measured by distance a patient can walk in 6 minute timeframe
Time Frame
12 Months
Title
Change from Baseline Lung X-Ray
Description
standard flat film x-ray
Time Frame
6 months, 12 months
Title
Change from Baseline SGOT Blood Testing
Description
Measure Blood Serum Glutamate Oxaloacetate Transaminase (SGOT) Measure Blood Elevation with liver damage
Time Frame
1 Month
Title
Change from Baseline SGPT Blood Testing
Description
Measure Blood Serum Glutamate Pyruvate Transaminase (SGPT) elevation with liver damage
Time Frame
1 Month
Title
Pulmonary Function Testing
Description
Measure Baseline Pulmonary Function (FEV/FEVi Measure)
Time Frame
Baseline, 6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert W Alexander, MD
Organizational Affiliation
Healeon Medical Inc
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Glenn C. Terry, MD
Organizational Affiliation
Global Alliance for Regenerative Medicine (GARM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regenevita LLC
City
Stevensville
State/Province
Montana
ZIP/Postal Code
59870
Country
United States
Facility Name
Global Alliance for Regenerative Medicine (GARM)
City
Roatan
State/Province
HN
Country
Honduras

12. IPD Sharing Statement

Plan to Share IPD
No
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Use of Autologous, Adult Adipose-Derived Stem/Stromal Cells In Chronic Lung Disorders

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