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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02161744
Recruitment Status : Active, not recruiting
First Posted : June 12, 2014
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Arkansas Heart Hospital

Tracking Information
First Submitted Date  ICMJE May 21, 2014
First Posted Date  ICMJE June 12, 2014
Last Update Posted Date September 5, 2018
Actual Study Start Date  ICMJE October 10, 2013
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2018)
Safety of adipose derived stem cells (ADSC) in Patient with COPD [ Time Frame: 12 months ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 11, 2014)
Frequency of AE and SAE during a 12 month follow up period. [ Time Frame: 12 months ]
Change History Complete list of historical versions of study NCT02161744 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2018)
  • Efficacy of ADSC in improving Shortness of Breath (SOB) [ Time Frame: 2, 6 and 12 months ]
    The change (decrease) in patient Shortness Of Breath (SOB) as compared to baseline, measured in breath per minute, after administration of adipose derived stem cells (ADSC)
  • Efficacy of ADSC In Pulmonary Function Test (PFTs) [ Time Frame: 2, 6, 12 months ]
    The change (improvement) in Pulmonary Function Test (PFTs) after administration of adipose derived stem cells (ADSC) as compared to baseline.
  • Efficacy of adipose derived stem cell in 6 MWT [ Time Frame: 2, 6, 12 months ]
    Improvement in patient ability to walk as measure using a 6 minute walk test ( in meter) as compared to baseline
  • Efficacy of adipose derived stem cells in patient's perceived exertion. [ Time Frame: 2, 6, 12 months ]
    The change from baseline in patient perceived exertion as measure using the modified BORG scale or Rate of perceive exertion (RPE) which ranges from 1(no perceived exertion at all) to 10 (maximum perceived exertion)
  • Efficacy in Quality of life using George's Respiratory Questionnaire [ Time Frame: 2, 6, 12 months ]
    The change from baseline in patient quality of life as measure using the George's Respiratory Questionnaire
  • Efficacy in Quality of life using the Chronic Respiratory questionnaires [ Time Frame: 2, 6, 12 months ]
    The change from baseline in patient quality of life as measure using the Chronic Respiratory Questionnaire
Original Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2014)
  • Less decrease of FEV1 (mL) compared to baseline. [ Time Frame: 6 weeks to 12 months ]
  • Less decrease of FEV1/FVC (%) compared to baseline [ Time Frame: 6 weeks to 12 months ]
  • Less decrease of DLCO (%) compared to baseline [ Time Frame: 6 week to 12 month ]
  • Less decrease of 6 minute walking distance (mm) compared to basline [ Time Frame: 6 week to 12 month ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability and Preliminary Efficacy of Adipose Derive Stem Cells for Patients With COPD
Official Title  ICMJE A Phase I Open- Label Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Autologous Adipose Stem Cell (Adult Human) to Subjects With Chronic Obstructive Pulmonary Disease
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.

Detailed Description STUDY DESIGN This is a Phase I open- label single-dose study in subjects with significant COPD. This is an expanded safety cohort. The investigators will enroll a minimum of 30 subjects. 6 week data of FEV1, FEV1/FVC, DLCO and 6 min walking distance values will be collected in all patients who are enrolled in the study (Baseline and 6 weeks after). Prior to the stem cell treatment, the patient will be assessed for 6 weeks by pulmonary function tests and 6 min walk tests. Then, patients will receive the infusion of stromal vascular fraction cells containing the aADSC (single intravenous dose). The standard therapy of COPD patients will not be interrupted during the duration of the study. Safety will be monitored on an ongoing basis, and an interim safety review will be conducted by the Investigator(s) and Sponsor after the first 20 patients have been enrolled and treated.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Phase I open label study to assess safety and tolerability
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease
Intervention  ICMJE Biological: ADSCs administration
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.
Other Name: Autologous Adipose Derived Stem Cells
Study Arms  ICMJE Experimental: ADSCs administration
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.
Intervention: Biological: ADSCs administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 4, 2018)
9
Original Estimated Enrollment  ICMJE
 (submitted: June 11, 2014)
60
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Males and Females ≥18 years.
  2. Cognitive competitiveness.
  3. Diagnosis of at least moderate COPD (postbronchodilator FEV1/FVC < 70% (<0.7), FEV1 < 80% predicted).
  4. Diffusing capacity impairment (DLCO) assessed by single breath test (corrected for alveolar volume, 'DLVA').
  5. Life expectancy greater than 12 months.
  6. 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.
  7. Reasonable expectation that patient will receive standard post-treatment care and attend all scheduled safety follow-up visits.
  8. No changes in active pulmonary medications for heart failure during the two weeks prior enrollment.

10. Written informed consent. 11. Non-smoker or Past smoker, with 20 pack-years or more history

Exclusion Criteria:

  1. Current smokers.
  2. Unstable coronary disease.
  3. Patients with industrial exposure to silica and/or asbestos or giant bullae.
  4. Uncontrolled seizure disorder.
  5. Dementia.
  6. Presence of immune deficiency or autoimmune disease.
  7. Alpha- 1 antitrypsin deficiency.
  8. Cor pulmonale or diastolic heart failure NYHA class III or IV
  9. Type 1 diabetes mellitus
  10. Complicated type 2 diabetes mellitus.
  11. Active tuberculosis or severe lung damage due to tuberculosis (extensive cavitation).
  12. History of cancer within the past 5 years.
  13. Clinically-significant hematologic, hepatic, or renal impairment as determined by screening clinical laboratory tests.
  14. 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.
  15. Porphyria.
  16. Allergy to sodium citrate or any "caine" type of local anesthetic.
  17. Abnormal findings could include: known HIV infection or other immunodeficiency state, chronic active viral infection (such as hepatitis B or C), acute systemic infections (defined as patients undergoing treatment with antibiotics), gastrointestinal tract bleeding, or any severe or acute concomitant illness or injury.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02161744
Other Study ID Numbers  ICMJE ICMS-2013-25
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Arkansas Heart Hospital
Study Sponsor  ICMJE Arkansas Heart Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jason Holder, MD Arkansas Heart Hospital
PRS Account Arkansas Heart Hospital
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP