Use of Autologous Stem/Stromal Cells In Chronic Lung Disorders: Obstructive (COPD) & Restrictive (RLD)

NCT03909750 | Suspended Phase 1 DMC

• 1 other identifier: GARM 2 Lung
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 2

Brief Summary

Pulmonary Disorders are often categorized as Obstructive or Restrictive disorders. This study will establish two channels of investigation, one group within each type of pulmonary dysfunction. State-of-the-Art Objective analytics will be employed to track patients from baseline and 6 month intervals for up to one year. 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. COPD is generally considered those who are able to better inspire air than to expel. Restrictive lung dysfunctions are generally considered those who are unable to achieve full inspiration function. Both can create some of the same symptoms, low Oxygen exchange, activity intolerance of exertion, shortness of breath (SOB), Pulmonary Hypertension, Loss of lung structure, Pneumothorax (in emphysema), may mandate supplemental Oxygen therapy, failure of airway mucus management (chronic bronchitis, bronchiectasis, etc), and other failure of lung function issues. Restrictive lung disorders represent a group of pulmonary function losses which are due to acquired fibrosis, congenital fibrotic disorders, functional airway damage (scarring), vascular abnormalities in arterial/venous supply, Air pollution and tobacco smoking, chemical inhalation damage, etc. are felt to be common contributor of these issues. Diagnostic testing is based on poor airflow measured by lung function studies and whose symptoms do not improve much with anti-asthma bronchodilators, steroids, and a variety of combination of topical medications. Study is an interventional study to document the safety and efficacy of use of cSVF in chronic broncho-pulmonary disease within both groups.

Conditions

COPD; Respiratory Insufficiency

Outcome Measures

Primary Outcomes (1)

• Safety-Pulmonary Function: occurrence or frequency of adverse or severe adverse events during study

  Pulmonary Function as occurrence or frequency of adverse or severe adverse events during study

  6 months evaluate function and adverse events

Secondary Outcomes (1)

• High Resolution Computerized Tomography - Lungs Fluidda Analysis

  Baseline and 6 month Comparative Study

Study Arms (3)

Lipoaspiration Microcannula ARM 1

EXPERIMENTAL

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

Procedure: Lipoaspiration

Isolation-Concentration Adipose cSVF ARM 2

EXPERIMENTAL

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

Procedure: AD-cSVF

Normal Saline IV ARM 3

EXPERIMENTAL

Sterile Normal Saline IV with cSVF

Procedure: Normal Saline IV

Interventions

Lipoaspiration PROCEDURE

Close syringe microcannula harvesting subdermal fat and perivascular stem/stromal cells

Lipoaspiration Microcannula ARM 1

AD-cSVF PROCEDURE

Isolation of AD-cSVF

Isolation-Concentration Adipose cSVF ARM 2

Normal Saline IV PROCEDURE

Normal Saline IV containing AD-cSVF

Normal Saline IV ARM 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented COPD or RLD by qualified Medical Provider
• History of Pulmonary Function Deficits or supplemental oxygen therapy

You may not qualify if:

• Cancer of the Lung
• Patient's on chemotherapy or radiation for Cancer (or History within 5 years)
• Inability to comply with Baseline and 6 month post-treatment HDCT lungs
• General health or inability or unwillingness or ability to provide informed consent for study
• History of lung transplantation
• Life expectancy of \<3 months due to concomitant illnesses
• Exposure to any investigational drug of procedure within 1 month prior to study enrollment which may interfere with interpretation of outcomes
• Illness which, in investigator's judgement, may interfere with patient's ability of comply with protocol, compromise patient safety, ability to provide informed consent or interfere with the interpretation of study outcomes.
• Subjects with chronic immunosuppressive or chemotherapeutic medication.
• Known drug or alcohol dependence or other factors which may interfere with study conduct or interpretation of result in opinion of investigators.
• Subjects with documented Alpha 2 Antitrypsin Deficiency (inherited lung and liver disorder)
• Patient with history of Hepatitis (except Hepatitis A history)

Sponsors & Collaborators

• Healeon Medical Inc: lead
• Robert W. Alexander, MD: collaborator

Study Sites (2)

Global Alliance for Regenerative Medicine-USA

Stevensville, Montana, 59870, United States

Location

Global Alliance of Regenerative Medicine (GARM) International

Roatán, Hn, Honduras, Honduras

Location

Related Publications (21)

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders

Study Officials

• Glenn C Terry, MD

  Global Alliance for Regenerative Medicine (GARM-HN)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 10, 2019
• Study Start: April 10, 2019
• Primary Completion: September 30, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

HO (1); US (1)