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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jan Stolk, Leiden University Medical Center
ClinicalTrials.gov Identifier:
NCT01306513
First received: March 1, 2011
Last updated: November 16, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention Phase
Emphysema
 Biological: autologous bone marrow derived mesenchymal stromal cells
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Emphysema
U.S. FDA Resources

Further study details as provided by Leiden University Medical Center:

Primary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

    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



Enrollment: 10
Study Start Date: October 2010
Study Completion Date: November 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cells Biological: autologous bone marrow derived mesenchymal stromal cells
Intravenous administration of autologous bone marrow-derived mesenchymal stromal cells.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306513

Locations
Netherlands
Department of Pulmonology, Leiden University Medical Center
Leiden, Netherlands, 2333 ZA
Sponsors and Collaborators
Leiden University Medical Center
Investigators
Study Chair: Jan Stolk, MD, PhD Leiden University Medical Center
  More Information

No publications provided

Responsible Party: Jan Stolk, MD PhD, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT01306513     History of Changes
Other Study ID Numbers: NL28562.000.09
Study First Received: March 1, 2011
Last Updated: November 16, 2012
Health Authority: Institutional Review Board Leiden University Medical Center, Netherlands ':'

Keywords provided by Leiden University Medical Center:
emphysema
lung volume reduction surgery
mesenchymal stromal cells

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 17, 2013