Paracrine Mechanisms of Bone Marrow Stem Cell Signalling in Chronic Heart Failure (BM-CHF)
![]() |
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. |
ClinicalTrials.gov Identifier: NCT01086787 |
Recruitment Status : Unknown
Verified March 2010 by University Medical Center Groningen.
Recruitment status was: Not yet recruiting
First Posted : March 15, 2010
Last Update Posted : June 11, 2010
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Heart Failure | Other: Surgery |
Study Type : | Observational |
Estimated Enrollment : | 125 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Paracrine Mechanisms of Bone Marrow Stem Cell Signalling in Chronic Heart Failure |
Study Start Date : | August 2010 |
Estimated Primary Completion Date : | August 2011 |
Estimated Study Completion Date : | December 2011 |

Group/Cohort | Intervention/treatment |
---|---|
Non heart failure patients
Patients without heart failure undergoing open chest surgery
|
Other: Surgery
Patients undergoing surgery for either cardiac surgery or orthopedic surgery |
Orthopedic patients
Patients without heart failure undergoing orthopedic surgery
|
Other: Surgery
Patients undergoing surgery for either cardiac surgery or orthopedic surgery |
Heart failure patients
Patients with heart failure undergoing open chest surgery.
|
Other: Surgery
Patients undergoing surgery for either cardiac surgery or orthopedic surgery |
- Paracrine properties of bone marrow cells from patients with heart failure [ Time Frame: 1 day ]To compare the paracrine properties of bone marrow-derived stem cells harvested from patients suffering chronic heart failure vs healthy subjects. In particular, we aim to determine if the cytoprotective, pro-angiogenic and anti-fibrotic effects mediated by bone marrow stem cells of heart failure patients are similar to those from healthy patients.
- To study preconditioning of different bone marrow stem cells with different cytokines [ Time Frame: 1 day ]
- To study in detail the temporal and spatial expression of paracrine factors in bone marrow stem cells in vitro, and to study the differences between bone marrow stem cells from patients with and without chronic heart failure [ Time Frame: 1 day ]
- To evaluate potential molecular mechanisms involved [ Time Frame: 1 day ]
- To find mechanisms to enhance expansion of different bone marrow stem cells in vitro [ Time Frame: 1 day ]
Biospecimen Retention: Samples With DNA

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
For all participants:
- Before any study-specific procedures, the appropriate written informed consent must be obtained.
-
Male and female older than 18 years of age.
For the cardiac patients:
- Being accepted for cardiothoracic surgery with the use of open chest surgery
-
A known left ventricular ejection fraction, either assessed by echocardiography, MUGA or MRI. If LVEF <40% a subject will be assigned to the chronic heart failure group, if LVEF >40% a subject will be assigned to the control group.
For the non-cardiac patients:
- Accepted for orthopedic surgery (e.g. total hip replacement) at the department of orthopedic surgery.
Exclusion Criteria:
- An unstable medical condition, defined as having been hospitalized for a non-cardiac condition within 4 weeks of screening, or otherwise unstable in the judgment of the investigator (e.g. at risk of complications or adverse events unrelated to study participation).
- Younger than 18 years of age.
- Clinical history of chronic kidney disease (at any point prior to registration).
- Any known hepatic disease.
- Recent (within 3 months) history of alcohol or illicit drug abuse disorder, based on self-report.
- Clinically significant abnormality in chemistry, hematology, or urinalysis parameters performed within the screening period.
- Participation in any investigational device or drug trial(s) or receiving investigational agent(s) within 30 days.
- Any condition (e.g. psychiatric illness, etc.) or situation that, in the investigator's opinion, could put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
-
Legally incompetent adults, for which reason what so ever.
For the non-cardiac patients:
- A known history of cardiovascular disease.

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 ClinicalTrials.gov identifier (NCT number): NCT01086787
Contact: W. T. Ruifrok, MD | +31 50 361 61 61 ext 10248 | w.t.ruifrok@thorax.umcg.nl | |
Contact: R. A. de Boer, MD, PhD | +31 50 361 61 61 ext 15381 | r.a.de.boer@thorax.umcg.nl |
Italy | |
Department of Heart, Blood and Lung , University of Pavia | |
Pavia, Italy | |
Contact: M. Gnecchi, MD, PhD massimiliano.gnecchi@unipv.it | |
Principal Investigator: M. Gnecchi, MD, PhD | |
Netherlands | |
University Medical Center Groningen | |
Groningen, Netherlands, 9700 RB | |
Contact: R. A. de Boer, MD, PhD +31 50 631 61 61 ext 15381 r.a.de.boer@thorax.umcg.nl | |
Contact: W. T. Ruifrok, MD +31 50 631 61 61 ext 10248 w.t.ruifrok@thorax.umcg.nl | |
Principal Investigator: W. T. Ruifrok, MD |
Principal Investigator: | W. T. Ruifrok, MD | University Medical Center Groningen | |
Study Director: | R. A. de Boer, MD, PhD | University Medical Center Groningen | |
Study Chair: | W. H. van Gilst, PhD | University Medical Center Groningen | |
Study Director: | M. Gnecchi, MD, PhD | University of Pavia | |
Principal Investigator: | L. Kleijn, MD | University Medical Center Groningen |
Responsible Party: | R.A. de Boer, MD, PhD, University Medical Center Groningen |
ClinicalTrials.gov Identifier: | NCT01086787 |
Other Study ID Numbers: |
WTR-ECG-5 |
First Posted: | March 15, 2010 Key Record Dates |
Last Update Posted: | June 11, 2010 |
Last Verified: | March 2010 |
Heart failure Bone marrow Bone marrow mononuclear cells |
Surgery Orthopedic surgery Cardiac surgery |
Heart Failure Heart Diseases Cardiovascular Diseases |