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Safety and Feasibility Study of Administration of Mesenchymal Stemcells for Treatment of Emphysema

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. Identifier: NCT01306513
Recruitment Status : Completed
First Posted : March 2, 2011
Last Update Posted : November 19, 2012
Information provided by (Responsible Party):
Jan Stolk, Leiden University Medical Center

Brief Summary:
The purpose of this study is to show safety and feasibility to administer patients own mesenchymal stem cells to show signs of repair of emphysematous lung tissue

Condition or disease Intervention/treatment Phase
Emphysema Biological: autologous bone marrow derived mesenchymal stromal cells Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Autologous Bone Marrow Derived Mesenchymal Stromal Cells Prior to Lung Volume Reduction Surgery for Severe Pulmonary Emphysema- a Phase I Safety and Feasibility Study
Study Start Date : October 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema

Arm Intervention/treatment
Experimental: cells Biological: autologous bone marrow derived mesenchymal stromal cells
Intravenous administration of autologous bone marrow-derived mesenchymal stromal cells.

Primary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 8 weeks ]

    Safety: rate and grade of (serious) adverse events in the study population using the WHO toxicity criteria. After infusion of MSC's investigators will score change in renal function, breathing rate, temperature, heart rate, and blood pressure.

    Feasibility: determination of the number of expanded MSCs in relation to the amount of autologous bone marrow collected, number of passages required and time to reach to study target dose

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Class GOLD III for COPD

Exclusion Criteria:

  • Patients with clinical and radiological evidence of bronchiectasis.
  • Patients suffering from renal- or hepatic failure.
  • A psychiatric, addictive, or any disorder that compromises ability to give truly informed consent for participation in this study.
  • Use of any investigational drug within 1 month prior to screening.
  • Patients with pulmonary hypertension, with mean PAP above 30 mmHg assessed by ultrasound of the chest or by transoesophageal ultrasound.
  • Documented HIV infection.
  • Active hepatitis B, hepatitis C or TB.
  • Subjects who currently have or who have had an opportunistic infection (e.g., herpes zoster, cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening.
  • Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, cardiac, neurologic, or cerebral disease (including demyelinating diseases such as multiple sclerosis).
  • Malignancy within the past 5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence).
  • History of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (such as nodes in the posterior triangle of the neck, infra-clavicular, epitrochlear, or periaortic areas), or splenomegaly.
  • Known recent substance abuse (drug or alcohol).
  • Poor tolerability of venepuncture or lack of adequate venous access for required blood sampling during the study period.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01306513

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Department of Pulmonology, Leiden University Medical Center
Leiden, Netherlands, 2333 ZA
Sponsors and Collaborators
Leiden University Medical Center
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Study Chair: Jan Stolk, MD, PhD Leiden University Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jan Stolk, MD PhD, Leiden University Medical Center Identifier: NCT01306513    
Other Study ID Numbers: NL28562.000.09
First Posted: March 2, 2011    Key Record Dates
Last Update Posted: November 19, 2012
Last Verified: November 2012
Keywords provided by Jan Stolk, Leiden University Medical Center:
lung volume reduction surgery
mesenchymal stromal cells
Additional relevant MeSH terms:
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Pulmonary Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases