- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02866721
Safety and Tolerability Study of Allogeneic Mesenchymal Stem Cell Infusion in Adults With Cystic Fibrosis (CEASE-CF)
A Phase I, Single Center, Open Label, Single Dose, Dose Escalation Study Assessing the Safety and Tolerability of AllogeneiC MEsenchymAl Stem CEll Infusion in Adults With Cystic Fibrosis-CEASE CF
This study is being done to test if it is safe to give stem cells to adult patients with Cystic Fibrosis (CF). The kind of stem cells we are studying are called allogeneic human mesenchymal stem cells or MSCs. MSCs are cells in the body that can grow into different types of cells and respond to various environmental situations. Allogeneic means the cells come from another person (a donor).
This study is only looking at whether or not it is safe to give the stem cells to adults with CF and how the infusion is tolerated. In the future, other studies may be done to see if stem cells can be a new therapeutic treatment for CF.
Stem cells, like other medical products that are intended to treat, cure or prevent disease, generally require approval from the U.S. Food and Drug Administration (FDA) before they can be marketed. The FDA has not approved any stem cell-based products for usual medical care, other than some specific blood forming stem cells for certain indications.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Ohio
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Cleveland, Ohio, United States, 44106
- University Hospitals Cleveland Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Cystic Fibrosis (CF) Subject Inclusion Criteria:
- Male or female ≥18 years of age
Confirmed diagnosis of CF as evidenced by 1 or more clinical features consistent with the CF phenotype and 1 or more of the following criteria:
- Sweat chloride equal to or greater than 60 milliequivalents per liter (mEq/L) by quantitative pilocarpine iontophoresis test (QPIT)
- 2 well-characterized, disease causing mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
- Clinically stable with no significant changes in health status within 2 weeks prior to screening.
- Forced expiratory volume in the first second (FEV1) ≥ 40% predicted for age based on the global lung function initiative equations at the screening visit
- Weight ≥ 40 kilograms at the screening visit
- Able to perform repeatable, consistent efforts in pulmonary function testing
- Written informed consent obtained from the subject.
CF Subject Exclusion Criteria:
- Use of an investigational agent within the 4-week period prior to Visit 1 (Day -42 to -10)
- Chronic daily (>10 mg) or alternate daily (>20 mg on alternate days) use of systemic corticosteroids within the 4 weeks prior to Visit 1 (Day -42 to -10) or initiation of any dosage of systemic corticosteroids within 72 hours prior to Visit 2 (Day 1).
- Use of hydroxychloroquine or immunosuppressants.
- Initiation of a new antibiotic (oral, intravenous, and/or inhaled) that is not part of the subject's maintenance regimen for treatment of acute respiratory symptoms within 2 weeks prior to screening through Visit 2 (Day 1)
- Initiation of any new chronic therapy (e.g., Pulmozyme®, hypertonic saline, Kalydeco®, Orkambi®, high-dose ibuprofen azithromycin, TOBI®, Cayston®, nebulized colistiin, bronchodilators, inhaled corticosteroids, etc.) within 4 weeks prior to screening
- Active treatment for non-tuberculous Mycobacteria
- History of a sputum culture positive for a Burkholderia cepacia complex organism in the previous 12 months.
- Current tobacco smoker
- Oxygen saturation < 92% on room air at Visit 1 (Day -42 to -10)
- History of pulmonary hypertension
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 times the upper limit of normal at screening, documented biliary cirrhosis, or portal hypertension
- Total bilirubin concentration > 1.2 milligram per deciliter (mg/dL) at screening
- Creatinine > 1.8 mg/dL at screening
- Pregnant, breastfeeding, or unwilling to practice birth control between Visit 2 (Day 1) and Telephone Call 3 (Day 56) (acceptable forms of contraception: abstinence, hormonal birth control, intrauterine device, or barrier method plus a spermicidal agent), unless surgically sterilized or postmenopausal
- Screening hematology with white blood cell count < 4.5 x 109 cells/liter, hematocrit < 30%, and platelets < 150 x 109 platelets/liter
- History of invasive cancer requiring systemic therapy
- History of organ transplantation
- Currently listed for lung transplantation or having potential to be listed for lung transplantation in the succeeding 12 calendar months from screening
- Subject unlikely to complete the study as determined by the Investigator
Inclusion Criteria for Healthy Volunteer Donors (NOTE: Enrollment for Healthy Volunteers is closed):
- Male/female age ≥ 18 years to ≤ 40 years
- Able to understand and sign consent form (a legally authorized representative will not be permitted)
Inclusion Criteria for CF Donors:
1. CF subject enrolled in the main study and consented to this optional procedure
Exclusion Criteria for both Healthy Volunteer (HV) Donors and CF Donors:
- Fever or current illness on the day of the cell collection
- Evidence of communicable disease
- Any significant change in health status within 2 weeks prior to cell collection that the Principal Investigator/Sub-Investigator deems relevant to exclude participation
- Subject reported history of organ transplantation
- Subject reported history of human immunodeficiency virus, hepatitis B or C, or syphilis
- For HV donors only, subject-reported known history of being diagnosed with cystic fibrosis (CF) or being a CF carrier (one copy of CF gene mutation)
- Positive screening blood test result for any infectious disease.
- For HV donors only, positive test result for CMV or a CF gene mutation.
- Pregnant, planning a pregnancy, or breast-feeding at screening
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Human Allogeneic Mesenchymal Stem Cells
One time intravenous (IV) Infusion of up to 5 x 10^6 allogeneic human mesenchymal stem cells per kilogram of body weight (hMSCs/kg).
A dose escalation using the "3+3" design will be employed.
The three doses are 1 x 10^6, 3 x 10^6, and 5 x 10^6 hMSCs/kg.
There is no placebo group.
All study participants will receive stem cells.
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A single dose, one time infusion (in the vein) of one of the following doses of human mesenchymal stem cells (hMSCs): 1 x 10^6, 3 x 10^6 or 5 x 10^6 human mesenchymal stem cells per kilogram body weight (hMSCs/kg) during Visit 2. A traditional 3+3 design will be utilized. Allogeneic mesenchymal stem cells (MSCs) will be derived from bone marrow aspirates from a healthy donor whose serum tests negative for cytomegalovirus (CMV) antibodies. Healthy donors will undergo tests for infectious disease and screening for 41 common cystic fibrosis transmembrane conductance regulator (CFTR) mutations. In addition, the MSCs will be validated for in vitro and in vivo efficacy and potency using the in vivo murine pre-clinical model of cystic fibrosis lung infection and inflammation.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants With a Dose Limiting Toxicity (DLT), Triggered by Occurrence in the First 24 Hours After Human Mesenchymal Stem Cell (hMSC) Infusion of Grade ≥3 Infusion-related Allergic Toxicities
Time Frame: 24 hours post infusion
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For this study, dose limiting toxicities included the emergence of infusion-related allergic adverse events as well as regimen related toxicities in the first 24 hours after hMSC infusion of a grade ≥ 3 as scored according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
This is the number of participants who experienced a dose limiting toxicity during the study.
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24 hours post infusion
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Number of Serious Adverse Events and Number of Non-Serious Adverse Events
Time Frame: 1 year
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Participants were followed for 12 months after human mesenchymal stem cell infusion.
All events from the infusion date through the end of follow-up were included.
This shows the total number of adverse events or serious adverse events occurring in each dosing cohort.
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1 year
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Number of Pulmonary Exacerbations Requiring Intravenous Antibiotics
Time Frame: 1 year
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Participants were followed for 12 months after human mesenchymal stem cell infusion.
All events occurring from the infusion date through the end of follow-up were included.
This shows the number of pulmonary exacerbations requiring intravenous antibiotics in each dosing cohort.
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1 year
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Forced Expiratory Volume in the First Second (FEV1) % Predicted at Baseline and 30 Minutes, 4 Hours, 24 Hours, 7 Days, 14 Days, 28 Days, 3 Months, 6 Months Post Human Mesenchymal Stem Cell Infusion.
Time Frame: Baseline and 30 minutes, 4 hours, 24 hours, 7 days, 14 days, 28 days, 3 months, 6 months Post Human Mesenchymal Stem Cell Infusion
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Lung function was followed for 6 months post human mesenchymal stem cell infusion.
This shows the mean forced expiratory volume in the first second (FEV1) percent predicted for each cohort throughout the study.
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Baseline and 30 minutes, 4 hours, 24 hours, 7 days, 14 days, 28 days, 3 months, 6 months Post Human Mesenchymal Stem Cell Infusion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Serum Inflammatory Markers - Calportectin Measurements at Baseline, Day 7, and Day 28
Time Frame: Baseline, Day 7, Day 28 post human mesenchymal stem cell infusion
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Serum inflammatory markers including Calprotectin were collected at baseline and at the visits 7 days and 28 days post human mesenchymal stem cell (hMSC) infusion.
Mean values with standard deviation are shown.
The lower limit for detection for calportectin was 88.3 picogram per millilitre.
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Baseline, Day 7, Day 28 post human mesenchymal stem cell infusion
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Serum Inflammatory Markers - Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Measurements at Baseline, Day 7, and Day 28
Time Frame: Baseline, Day 7, Day 28 post human mesenchymal stem cell infusion
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Serum inflammatory markers including Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) were collected at baseline and at the visits 7 days and 28 days post human mesenchymal stem cell (hMSC) infusion.
Mean values with standard deviation are shown.
The lower limit for detection for GM-CSF was 2.6 picograms per milliliter.
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Baseline, Day 7, Day 28 post human mesenchymal stem cell infusion
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Serum Inflammatory Markers - Interleukin-1 (IL-1) Measurements at Baseline, Day 7, and Day 28
Time Frame: Baseline, Day 7, Day 28 post human mesenchymal stem cell infusion
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Serum inflammatory markers including interleukin -1 (IL-1) were collected at baseline and at the visits 7 days and 28 days post human mesenchymal stem cell (hMSC) infusion.
Mean values with standard deviation are shown.
The lower limit for detection for IL-1 was 13.1 picograms per milliliter.
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Baseline, Day 7, Day 28 post human mesenchymal stem cell infusion
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Serum Inflammatory Markers - Interleukin-17 (IL-17) Measurements at Baseline, Day 7, and Day 28
Time Frame: Baseline, Day 7, Day 28 post human mesenchymal stem cell infusion
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Serum inflammatory markers including interleukin -17 (IL-17) were collected at baseline and at the visits 7 days and 28 days post human mesenchymal stem cell (hMSC) infusion.
Mean values with standard deviation are shown.
The lower limit for detection for IL-17 was 13.5 picograms per milliliter.
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Baseline, Day 7, Day 28 post human mesenchymal stem cell infusion
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Serum Inflammatory Markers - Interleukin-6 (IL-6) Measurements at Baseline, Day 7, and Day 28
Time Frame: Baseline, Day 7, Day 28 post human mesenchymal stem cell infusion
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Serum inflammatory markers including interleukin -6 (IL-6) were collected at baseline and at the visits 7 days and 28 days post human mesenchymal stem cell (hMSC) infusion.
Mean values with standard deviation are shown.
The lower limit for detection for IL-6 was 13.5 picograms per milliliter.
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Baseline, Day 7, Day 28 post human mesenchymal stem cell infusion
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Serum Inflammatory Markers - Interleukin-8 (IL-8) Measurements at Baseline, Day 7, and Day 28
Time Frame: Baseline, Day 7, Day 28 post human mesenchymal stem cell infusion
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Serum inflammatory markers including interleukin -8 (IL-8) were collected at baseline and at the visits 7 days and 28 days post human mesenchymal stem cell (hMSC) infusion.
Mean values with standard deviation are shown.
The lower limit for detection for IL-8 was 13.9 picograms per milliliter.
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Baseline, Day 7, Day 28 post human mesenchymal stem cell infusion
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Serum Inflammatory Markers - Myeloperoxidase (MPO) Measurements at Baseline, Day 7, and Day 28
Time Frame: Baseline, Day 7, Day 28 post human mesenchymal stem cell infusion
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Serum inflammatory markers including myeloperoxidase (MPO) were collected at baseline and at the visits 7 days and 28 days post human mesenchymal stem cell (hMSC) infusion.
Mean values with standard deviation are shown.
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Baseline, Day 7, Day 28 post human mesenchymal stem cell infusion
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Serum Inflammatory Markers - Tumor Necrosis Factor Alpha (TNF-a) Measurements at Baseline, Day 7, and Day 28
Time Frame: Baseline, Day 7, Day 28 post human mesenchymal stem cell infusion
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Serum inflammatory markers including tumor necrosis factor alpha (TNF-a) were collected at baseline and at the visits 7 days and 28 days post human mesenchymal stem cell (hMSC) infusion.
Mean values with standard deviation are shown.
The lower limit of detection for TNF-a was 12.9 picograms per millilter.
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Baseline, Day 7, Day 28 post human mesenchymal stem cell infusion
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Sputum Inflammatory Markers - Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Measurements at Baseline, Day 7, and Day 28
Time Frame: Baseline, Day 7, Day 28 post human mesenchymal stem cell infusion
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Sputum inflammatory markers including granulocyte-macrophage colony-stimulating factor (GM-CSF) were collected at baseline and at the visits 7 days and 28 days post human mesenchymal stem cell (hMSC) infusion.
Mean values with range are shown.
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Baseline, Day 7, Day 28 post human mesenchymal stem cell infusion
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Sputum Inflammatory Markers - Interleukin-1 (IL-1) Measurements at Baseline, Day 7, and Day 28
Time Frame: Baseline, Day 7, Day 28 post human mesenchymal stem cell infusion
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Sputum inflammatory markers including interleukin-1 (IL-1) were collected at baseline and at the visits 7 days and 28 days post human mesenchymal stem cell (hMSC) infusion.
Mean values with range are shown.
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Baseline, Day 7, Day 28 post human mesenchymal stem cell infusion
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Sputum Inflammatory Markers - Interleukin-10 (IL-10) Measurements at Baseline, Day 7, and Day 28
Time Frame: Baseline, Day 7, Day 28 post human mesenchymal stem cell infusion
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Sputum inflammatory markers including interleukin-10 (IL-10) were collected at baseline and at the visits 7 days and 28 days post human mesenchymal stem cell (hMSC) infusion.
Mean values with range are shown.
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Baseline, Day 7, Day 28 post human mesenchymal stem cell infusion
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Sputum Inflammatory Markers - Interleukin-17 (IL-17) Measurements at Baseline, Day 7, and Day 28
Time Frame: Baseline, Day 7, Day 28 post human mesenchymal stem cell infusion
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Sputum inflammatory markers including interleukin-17 (IL-17) were collected at baseline and at the visits 7 days and 28 days post human mesenchymal stem cell (hMSC) infusion.
Mean values with range are shown.
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Baseline, Day 7, Day 28 post human mesenchymal stem cell infusion
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Sputum Inflammatory Markers - Interleukin-6 (IL-6) Measurements at Baseline, Day 7, and Day 28
Time Frame: Baseline, Day 7, Day 28 post human mesenchymal stem cell infusion
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Sputum inflammatory markers including interleukin-6 (IL-6) were collected at baseline and at the visits 7 days and 28 days post human mesenchymal stem cell (hMSC) infusion.
Mean values with range are shown.
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Baseline, Day 7, Day 28 post human mesenchymal stem cell infusion
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Sputum Inflammatory Markers - Interleukin-8 (IL-8) Measurements at Baseline, Day 7, and Day 28
Time Frame: Baseline, Day 7, Day 28 post human mesenchymal stem cell infusion
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Sputum inflammatory markers including interleukin-8 (IL-8) were collected at baseline and at the visits 7 days and 28 days post human mesenchymal stem cell (hMSC) infusion.
Mean values with range are shown.
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Baseline, Day 7, Day 28 post human mesenchymal stem cell infusion
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Sputum Inflammatory Markers - Macrophage Inflammatory Protein-3 Alpha (MIP-3a) Measurements at Baseline, Day 7, and Day 28
Time Frame: Baseline, Day 7, Day 28 post human mesenchymal stem cell infusion
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Sputum inflammatory markers including macrophage inflammatory protein-3 alpha (MIP-3a) were collected at baseline and at the visits 7 days and 28 days post human mesenchymal stem cell (hMSC) infusion.
Mean values with range are shown.
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Baseline, Day 7, Day 28 post human mesenchymal stem cell infusion
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Sputum Inflammatory Markers - Tumor Necrosis Factor Alpha (TNF-a) Measurements at Baseline, Day 7, and Day 28
Time Frame: Baseline, Day 7, Day 28 post human mesenchymal stem cell infusion
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Sputum inflammatory markers including tumor necrosis factor alpha (TNF-a) were collected at baseline and at the visits 7 days and 28 days post human mesenchymal stem cell (hMSC) infusion.
Mean values with range are shown.
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Baseline, Day 7, Day 28 post human mesenchymal stem cell infusion
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Collaborators and Investigators
Investigators
- Principal Investigator: Erica A. Roesch, MD, University Hospitals Cleveland Medical Center
Publications and helpful links
General Publications
- Ivy SP, Siu LL, Garrett-Mayer E, Rubinstein L. Approaches to phase 1 clinical trial design focused on safety, efficiency, and selected patient populations: a report from the clinical trial design task force of the national cancer institute investigational drug steering committee. Clin Cancer Res. 2010 Mar 15;16(6):1726-36. doi: 10.1158/1078-0432.CCR-09-1961. Epub 2010 Mar 9.
- 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.
- Gebler A, Zabel O, Seliger B. The immunomodulatory capacity of mesenchymal stem cells. Trends Mol Med. 2012 Feb;18(2):128-34. doi: 10.1016/j.molmed.2011.10.004. Epub 2011 Nov 25.
- Lalu MM, McIntyre L, Pugliese C, Fergusson D, Winston BW, Marshall JC, Granton J, Stewart DJ; Canadian Critical Care Trials Group. Safety of cell therapy with mesenchymal stromal cells (SafeCell): a systematic review and meta-analysis of clinical trials. PLoS One. 2012;7(10):e47559. doi: 10.1371/journal.pone.0047559. Epub 2012 Oct 25.
- Caplan AI. Why are MSCs therapeutic? New data: new insight. J Pathol. 2009 Jan;217(2):318-24. doi: 10.1002/path.2469.
- Bonfield TL, Caplan AI. Adult mesenchymal stem cells: an innovative therapeutic for lung diseases. Discov Med. 2010 Apr;9(47):337-45.
- Dimarino AM, Caplan AI, Bonfield TL. Mesenchymal stem cells in tissue repair. Front Immunol. 2013 Sep 4;4:201. doi: 10.3389/fimmu.2013.00201.
- Antunes MA, Laffey JG, Pelosi P, Rocco PR. Mesenchymal stem cell trials for pulmonary diseases. J Cell Biochem. 2014 Jun;115(6):1023-32. doi: 10.1002/jcb.24783.
- Gupta N, Su X, Popov B, Lee JW, Serikov V, Matthay MA. Intrapulmonary delivery of bone marrow-derived mesenchymal stem cells improves survival and attenuates endotoxin-induced acute lung injury in mice. J Immunol. 2007 Aug 1;179(3):1855-63. doi: 10.4049/jimmunol.179.3.1855.
- Sutton MT, Fletcher D, Ghosh SK, Weinberg A, van Heeckeren R, Kaur S, Sadeghi Z, Hijaz A, Reese J, Lazarus HM, Lennon DP, Caplan AI, Bonfield TL. Antimicrobial Properties of Mesenchymal Stem Cells: Therapeutic Potential for Cystic Fibrosis Infection, and Treatment. Stem Cells Int. 2016;2016:5303048. doi: 10.1155/2016/5303048. Epub 2016 Jan 26.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Protocol CF-MSC-01
- DASENB15A0 (Other Grant/Funding Number: Cystic Fibrosis Foundation Therapeutics)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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