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

NCT03909750 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-10-01

No results posted yet for this study

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

Interventions

PROCEDURE

Lipoaspiration

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

PROCEDURE

AD-cSVF

Isolation of AD-cSVF

PROCEDURE

Normal Saline IV

Normal Saline IV containing AD-cSVF

Sponsors & Collaborators

  • Robert W. Alexander, MD

    collaborator UNKNOWN

  • Healeon Medical Inc

    lead INDUSTRY

Principal Investigators

  • Glenn C Terry, MD · Global Alliance for Regenerative Medicine (GARM-HN)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-10
Primary Completion
2025-09-30
Completion
2026-09-30

Countries

  • United States
  • Honduras

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03909750 on ClinicalTrials.gov