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

NCT01306513 | Completed Phase 1

• 1 other identifier: NL28562.000.09
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Emphysema

Keywords

emphysema; lung volume reduction surgery; mesenchymal stromal cells

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  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

  8 weeks

Study Arms (1)

cells

EXPERIMENTAL

Biological: autologous bone marrow derived mesenchymal stromal cells

Interventions

autologous bone marrow derived mesenchymal stromal cells BIOLOGICAL

Intravenous administration of autologous bone marrow-derived mesenchymal stromal cells.

cells

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Class GOLD III for COPD

You may not qualify if:

• 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.

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Department of Pulmonology, Leiden University Medical Center

Leiden, 2333 ZA, Netherlands

Location

Related Publications (1)

• Stolk J, Broekman W, Mauad T, Zwaginga JJ, Roelofs H, Fibbe WE, Oostendorp J, Bajema I, Versteegh MI, Taube C, Hiemstra PS. A phase I study for intravenous autologous mesenchymal stromal cell administration to patients with severe emphysema. QJM. 2016 May;109(5):331-6. doi: 10.1093/qjmed/hcw001. Epub 2016 Jan 27.

  PMID: 26819296 DERIVED

MeSH Terms

Conditions

Emphysema

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jan Stolk, MD, PhD

  Leiden University Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: March 1, 2011
• First Posted: March 2, 2011
• Study Start: October 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 19, 2012

Record last verified: 2012-11

Locations

NL (1)