Randomised, double blind, placebo controlled trial of intramyocardial injection of autologous bone marrow cells in no-option patients with refractory angina pectoris and documented ischaemia

ISRCTN	ISRCTN58194927
DOI	https://doi.org/10.1186/ISRCTN58194927
Protocol serial number	NTR400
Sponsor	Leiden University Medical Centre (LUMC) (The Netherlands)
Funder	Leiden University Medical Centre (LUMC) (Netherlands)

Submission date: 27/01/2006
Registration date: 27/01/2006
Last edited: 09/01/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr S L M A Beeres
Scientific

Leiden University Medical Centre
Department of Cardiology
P.O. Box 9600
Leiden
2300 RC
Netherlands

Phone	+31 (0)71 526 2020
Email	s.l.m.a.beeres@lumc.nl

Study information

Primary study design	Interventional
Study design	Randomised, double-blind, placebo controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	The aim of this study is to determine the safety and efficacy of intramyocardial injection of autologous bone marrow cells in no-option patients with refractory angina pectoris and documented myocardial ischaemia.
Ethics approval(s)	Received from the local medical ethics committee
Health condition(s) or problem(s) studied	Angina pectoris, myocardial ischaemia
Intervention	After written informed consent has been obtained, quality of life and exercise capacity will be investigated. In addition myocardial function and perfusion will be documented. Bone marrow will be aspired from the iliac crest under local anesthesia. Patients will be randomised to receive bone marrow cells or placebo. In all patients NOGA™ mapping will be performed with subsequent intramyocardial injection of autologous bone marrow-derived mononuclear cells or placebo. Quality of life and exercise capacity will be re-assessed at 3 and 6 months follow-up. In addition, changes in myocardial function and perfusion will be evaluated at 3 months follow-up.
Intervention type	Other
Primary outcome measure(s)	The change in myocardial perfusion (SPECT) at 3 months follow-up relative to baseline.
Key secondary outcome measure(s)	Efficacy: 1. Clinical end points: 1.1. Angina frequency 1.2. Canadian cardiovascular society score 1.3. Quality of life 1.4. Exercise capacity 2. Functional end points: 2.1. Change in left ventricular (LV) ejection fraction at 3 months follow-up 2.2. Regional myocardial function on a segmental base at 3 months follow-up 3. Safety: 3.1. Occurrence of arrhythmias 3.2. Pericardial effusion greater than 5 mm (echo) 3.3. Myocardial damage 3.4. Severe inflammation
Completion date	01/05/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	40
Key inclusion criteria	1. Severe refractory angina despite optimal medical therapy 2. Reversible ischaemia on gated-single photon emission computed tomography (SPECT) 3. Not a candidate for (repeat) revascularisation (coronary artery bypass graft [CABG] or percutaneous coronary intervention [PCI]) 4. Male or female, greater than 18 years old 5. Patients must be stable (e.g. not be in a setting of life-threatening heart failure) 6. Written informed consent
Key exclusion criteria	1. Acute myocardial infarction, PCI or CABG within 6 months of enrolment in the study 2. History of malignancy (except low grade and fully resolved non-melanoma skin malignancy) 3. Unexplained haematological or biochemical abnormalities 4. Concurrent participation in a study using an experimental drug or an experimental procedure within 6 months before the injection procedure 5. Other severe concurrent illnesses (e.g. active infection, aortic stenosis, renal failure) 6. Bleeding diathesis or human immunodeficiency virus (HIV) infection 7. Inability to follow the protocol and comply with follow-up requirements
Date of first enrolment	01/05/2005
Date of final enrolment	01/05/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

Leiden University Medical Centre

Leiden
2300 RC
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	20/05/2009	Yes	No
Results article	results	01/03/2011	Yes	No
Results article	results	01/11/2012	Yes	No