Safety, Tolerability and Preliminary Efficacy of Adipose Derive Stem Cells for Patients With COPD

NCT02161744 | Terminated Phase 1

• 1 other identifier: ICMS-2013-25
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is: 1.- to assess the safety and tolerability of autologous adipose derived stem cells (aADSC) administered intravenously in patients with chronic obstructive pulmonary disease, and 2.- to assess if this therapy results in less decrease of lung function parameters (FEV1, FEV1/FVC and 6 min walking distance) compared with a control baseline of 6 weeks. Patients will be followed up for 12 months after the therapy.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Adipose derived stem cells; Stromal vascular fraction cells; Pulmonary Function Tests; Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Safety of adipose derived stem cells (ADSC) in Patient with COPD

  Safety/tolerability of Adipose Derived Stem Cell (ADSC) in patients with Chronic Obstructive Pulmonary Disease (COPD) during the twelve-month study period as determined by the incidence and severity of of adverse events.

  12 months

Secondary Outcomes (6)

• Efficacy of ADSC in improving Shortness of Breath (SOB)

  2, 6 and 12 months

• Efficacy of ADSC In Pulmonary Function Test (PFTs)

  2, 6, 12 months

• Efficacy of adipose derived stem cell in 6 MWT

  2, 6, 12 months

• Efficacy of adipose derived stem cells in patient's perceived exertion.

  2, 6, 12 months

• Efficacy in Quality of life using George's Respiratory Questionnaire

  2, 6, 12 months

Study Arms (1)

ADSCs administration

EXPERIMENTAL

Patients with Chronic Obstructive Pulmonary Disease will be treated with a single dose of autologous adipose derived stem cells. Stem cells will be isolated using standard Lipoaspiration procedure under sterile conditions.

Biological: ADSCs administration

Interventions

ADSCs administration BIOLOGICAL

100- 240 cc of lipoaspirate will be extracted from the patient. The stromal vascular fraction (SVF) will be isolated with minimal manipulation. The cell pellet will be reconstituted in saline solution and administered intravenously to the patient.

Also known as: Autologous Adipose Derived Stem Cells

ADSCs administration

Eligibility Criteria

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

You may qualify if:

• Males and Females ≥18 years.
• Cognitive competitiveness.
• Diagnosis of at least moderate COPD (postbronchodilator FEV1/FVC \< 70% (\<0.7), FEV1 \< 80% predicted).
• Diffusing capacity impairment (DLCO) assessed by single breath test (corrected for alveolar volume, 'DLVA').
• Life expectancy greater than 12 months.
• Ability to understand and provide signed informed consent, or have a designated legal guardian or spouse legally able and willing to make such decisions on the subject's behalf.
• Reasonable expectation that patient will receive standard post-treatment care and attend all scheduled safety follow-up visits.
• No changes in active pulmonary medications for heart failure during the two weeks prior enrollment.
• \. Written informed consent. 11. Non-smoker or Past smoker, with 20 pack-years or more history

You may not qualify if:

• Current smokers.
• Unstable coronary disease.
• Patients with industrial exposure to silica and/or asbestos or giant bullae.
• Uncontrolled seizure disorder.
• Dementia.
• Presence of immune deficiency or autoimmune disease.
• Alpha- 1 antitrypsin deficiency.
• Cor pulmonale or diastolic heart failure NYHA class III or IV
• Type 1 diabetes mellitus
• Complicated type 2 diabetes mellitus.
• Active tuberculosis or severe lung damage due to tuberculosis (extensive cavitation).
• History of cancer within the past 5 years.
• Clinically-significant hematologic, hepatic, or renal impairment as determined by screening clinical laboratory tests.
• Systemic corticosteroids, cytostatics, immunosuppressive drug therapy (cyclophosphamide, methotrexate, cyclosporine, azathioprine, etc.), and DNA depleting or cytotoxic drugs taken within four weeks prior to study treatment.
• Porphyria.

Sponsors & Collaborators

• Arkansas Heart Hospital: lead

Study Sites (2)

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Arkansas Site Management Services LLC

Little Rock, Arkansas, 72211, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Jason Holder, MD

  Arkansas Heart Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase I open label study to assess safety and tolerability

Study Record Dates

• First Submitted: May 21, 2014
• First Posted: June 12, 2014
• Study Start: October 10, 2013
• Primary Completion: October 29, 2018
• Study Completion: October 29, 2018
• Last Updated: January 27, 2020

Record last verified: 2020-01

Locations

US (2)