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

NCT02946658 | Suspended Phase 1 DMC

• 1 other identifier: RGV-GARM 2
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 2

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.

Conditions

Lung Disease

Keywords

COPD, Emphysema

Outcome Measures

Primary Outcomes (1)

• Safety - Pulmonary Function

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

  12 months Evaluate Function and Adverse Events

Secondary Outcomes (7)

• Change from Baseline Respiratory Rate

  1 month, 6 month, 1 year

• GOLD Classification

  1 year

• Change from baseline 6 Minute Walk Test

  12 Months

• Change from Baseline Lung X-Ray

  6 months, 12 months

• Change from Baseline SGOT Blood Testing

  1 Month

Study Arms (3)

Lipoaspiration Arm 1

EXPERIMENTAL

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

Procedure: lipoaspiration

AD-cSVF Arm 2

EXPERIMENTAL

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

Procedure: ADcSVF

Normal Saline IV Arm 3

EXPERIMENTAL

Normal Saline IV with AD-cSVF cells

Procedure: Normal Saline IV

Interventions

lipoaspiration PROCEDURE

Closed syringe harvesting subdermal fat

Lipoaspiration Arm 1

ADcSVF PROCEDURE

Isolation of AD-cSVF

AD-cSVF Arm 2

Normal Saline IV PROCEDURE

Normal Saline IV containing AD-cSVF

Normal Saline IV Arm 3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Healeon Medical Inc: lead
• Terry, Glenn C., M.D.: collaborator

Study Sites (2)

Regenevita LLC

Stevensville, Montana, 59870, United States

Location

Global Alliance for Regenerative Medicine (GARM)

Roatán, HN, Honduras

Location

Related Publications (22)

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• Inamdar AC, Inamdar AA. Mesenchymal stem cell therapy in lung disorders: pathogenesis of lung diseases and mechanism of action of mesenchymal stem cell. Exp Lung Res. 2013 Oct;39(8):315-27. doi: 10.3109/01902148.2013.816803. Epub 2013 Aug 30.

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MeSH Terms

Conditions

Lung Diseases; Pulmonary Disease, Chronic Obstructive; Emphysema

Condition Hierarchy (Ancestors)

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

Study Officials

• Robert W Alexander, MD

  Healeon Medical Inc

  PRINCIPAL INVESTIGATOR

• Glenn C. Terry, MD

  Global Alliance for Regenerative Medicine (GARM)

  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: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Science

Study Record Dates

• First Submitted: October 3, 2016
• First Posted: October 27, 2016
• Study Start: October 1, 2016
• Primary Completion (Estimated): August 14, 2026
• Study Completion (Estimated): August 14, 2027
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); HO (1)