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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 March 2024 |
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Main ID: |
NCT02946658 |
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Date of registration:
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03/10/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Use of Autologous, Adult Adipose-Derived Stem/Stromal Cells In Chronic Lung Disorders
ADcSVF-COPD |
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Scientific title:
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Use of Autologous, Adult Adipose-Derived Stem/Stromal Cells (AD-cSVF) in Chronic Lung Disorders |
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Date of first enrolment:
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October 2016 |
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Target sample size:
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100 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02946658 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Honduras
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United States
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Contacts
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Name:
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Glenn C. Terry, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Global Alliance for Regenerative Medicine (GARM) |
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Name:
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Robert W Alexander, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Healeon Medical Inc |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Prior Diagnosis of moderate to severe COPD
- GOLD II a, III, IV
Exclusion Criteria:
- 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)
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Lung Disease
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Intervention(s)
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Procedure: ADcSVF
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Procedure: Normal Saline IV
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Procedure: lipoaspiration
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Primary Outcome(s)
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Safety - Pulmonary Function
[Time Frame: 12 months Evaluate Function and Adverse Events]
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Secondary Outcome(s)
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Change from baseline 6 Minute Walk Test
[Time Frame: 12 Months]
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Pulmonary Function Testing
[Time Frame: Baseline, 6 Months]
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Change from Baseline SGPT Blood Testing
[Time Frame: 1 Month]
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Change from Baseline Lung X-Ray
[Time Frame: 6 months, 12 months]
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Change from Baseline SGOT Blood Testing
[Time Frame: 1 Month]
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Change from Baseline Respiratory Rate
[Time Frame: 1 month, 6 month, 1 year]
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GOLD Classification
[Time Frame: 1 year]
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Secondary ID(s)
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RGV-GARM 2
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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