Registry of Cell Therapy in Non-Ischemic Dilated Cardiomyopathy
RECORD
1 other identifier
observational
250
1 country
1
Brief Summary
Although several studies have demonstrated beneficial effects of stem cell therapy in patients with non-ischemic dilated cardiomyopathy, the long term benefits and predictors of response to therapy remain undefined. The aim of this registry is to pool long-term clinical data in patients with non-ischemic dilated cardiomyopathy undergoing autologous cell therapy in an attempt to better define predictors of response to such treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2005
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 12, 2015
CompletedFirst Posted
Study publicly available on registry
May 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
July 3, 2024
July 1, 2024
22 years
May 12, 2015
July 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Transplantation-free survival
Survival after 5 years without undergoing heart transplantation
5 years
Secondary Outcomes (4)
Changes in left ventricular ejection fraction
5 years
Changes in left ventricular dimensions
5 years
Changes in left ventricular diastolic function
5 years
Changes in right ventricular function
5 years
Other Outcomes (2)
Changes in exercise capacity
5 years
Changes in NT-proBNP
5 years
Interventions
All patients received granulocyte-colony stimulating factor (G-CSF; 5 mg/kg, 5 days). CD34+ cell were then collected by apheresis and injected transendocardially or intracororonary.
Eligibility Criteria
All patients enrolled in clinical trials of stem cell therapy in non-ischemic dilated cardiomyopathy at UMC Ljubljana from January, 2005 will be enrolled.
You may not qualify if:
- Patients with acute multi-organ failure or a history of hematologic neoplasms were not included.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UMC Ljubljana
Ljubljana, 1000, Slovenia
Related Publications (2)
Frljak S, Poglajen G, Zemljic G, Cerar A, Haddad F, Terzic A, Vrtovec B. Larger End-Diastolic Volume Associates With Response to Cell Therapy in Patients With Nonischemic Dilated Cardiomyopathy. Mayo Clin Proc. 2020 Oct;95(10):2125-2133. doi: 10.1016/j.mayocp.2020.02.031.
PMID: 33012343DERIVEDBervar M, Kozelj M, Poglajen G, Sever M, Zemljic G, Frljak S, Cukjati M, Cernelc P, Haddad F, Vrtovec B. Effects of Transendocardial CD34+ Cell Transplantation on Diastolic Parameters in Patients with Nonischemic Dilated Cardiomyopathy. Stem Cells Transl Med. 2017 Jun;6(6):1515-1521. doi: 10.1002/sctm.16-0331. Epub 2017 Mar 11.
PMID: 28296283DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bojan Vrtovec, MD, PhD
UMC Ljubljana
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Director, Advanced Heart Failure and Transplantation Center
Study Record Dates
First Submitted
May 12, 2015
First Posted
May 15, 2015
Study Start
January 1, 2005
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
July 3, 2024
Record last verified: 2024-07