Long-term Evaluation of Patients Receiving Bone Marrow-derived Cell Administration for Heart Disease (BMC registry)
This study is currently recruiting participants.
Verified September 2012 by Johann Wolfgang Goethe University Hospitals
Sponsor:
Johann Wolfgang Goethe University Hospitals
Information provided by (Responsible Party):
A. M. Zeiher, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00962364
First received: August 19, 2009
Last updated: September 19, 2012
Last verified: September 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | August 19, 2009 | ||||||||
| Last Updated Date | September 19, 2012 | ||||||||
| Start Date ICMJE | October 2001 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
Evaluation of procedural and long-term safety of intracoronary administration of bone marrow cells for the treatment for cardiac disease [ Time Frame: 10 years ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00962364 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Long-term Evaluation of Patients Receiving Bone Marrow-derived Cell Administration for Heart Disease | ||||||||
| Official Title ICMJE | Long-term Evaluation and Follow-up Care of Patients Receiving Intracoronary Bone Marrow-derived Cell Administration for Heart Disease | ||||||||
| Brief Summary | This study will provide follow-up information and care of patients who have undergone autologous intracoronary bone marrow cell administration at our institution. Patients are monitored for their response to treatment, progression of heart failure and coronary artery disease, and potential later occurring effects of the administered bone marrow cells. Patients are eligible for this follow-up study if they have received their first intracoronary bone marrow cell administration for the treatment of cardiac disease at our institution from 2001 ongoing. Participants are generally seen in the clinic at 12 months and 5 years after cell administration, in the meantime regular yearly telephone contacts are performed until 10 years after cell transplantation. The detailed description contains the planned procedures that are performed during the clinical visits and, if necessary, at additional contacts. |
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| Detailed Description | In detail, the following procedures are performed during the clinical visits and, if necessary, at additional contacts:
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: Serum and plasma from peripheral blood and bone marrow may me retained |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients suffering from heart disease with consecutive signs of heart failure, treated in our clinic or being referred for cell therapy |
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| Condition ICMJE |
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| Intervention ICMJE | Biological: autologous bone marrow-derived cells
autologous bone marrow-derived cells isolated by density gradient centrifugation from 50 ml bone marrow aspirate obtained under local anesthesia |
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| Study Group/Cohort (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 1500 | ||||||||
| Completion Date | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Clinical diagnosis of heart disease with signs and symptoms of heart failure due to
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Germany | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00962364 | ||||||||
| Other Study ID Numbers ICMJE | 201-01-BMC-Reg | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | A. M. Zeiher, Johann Wolfgang Goethe University Hospitals | ||||||||
| Study Sponsor ICMJE | Johann Wolfgang Goethe University Hospitals | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Johann Wolfgang Goethe University Hospitals | ||||||||
| Verification Date | September 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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