Clinical trial NCT01449032: MesenchYmal STROMAL CELL Therapy in Patients With Chronic Myocardial Ischemia (MyStromalCell Trial)
Official title: MesenchYmal STROMAL CELL Therapy in Patients With Chronic Myocardial Ischemia (MyStromalCell Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Ischemic Heart Disease
Keywords: Patients
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2011-10-07
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Coronary artery disease (CAD) is the most common cause of death and a major cause of hospital admissions for acute chest pain. In spite of improved treatments still many patients with CAD have daily attacks of severe chest pain and severely reduced life quality.

The investigators have established a double-blind placebo-controlled trial in patients with CAD to test efficacy and safety of treatment with adipose derived stem cells to improve perfusion in the heart muscle and exercise capacity, and reduce the patient's symptoms.

Detailed description: In an open single centre pilot study we have evaluated the safety and efficacy of MSC treatment to improve heart muscle perfusion in patients with chronic CAD. Patients treated with MSCs had significant increased exercise capacity, reduction in angina, angina attacks and medication and in life quality at 6 months follow-up. For all the parameters there was a tendency towards improved outcome with increasing number of cells. The treatment with MSCs was safe.

The investigators have now established a double-blind placebo-controlled trial in patients with CAD to test efficacy and safety of treatment with MSCs to improve perfusion in the heart muscle and exercise capacity, and reduce the patient's symptoms.

Eligibility criteria: Inclusion Criteria:

* CCS III - IV
* Coronary artery stenosis/occlusion not treatable with invasive procedures
* LVEF \> 40%
* ETT between 2 - 10 min

Exclusion Criteria:

* Valvular heart disease
* FEV1 \< 1
* Severe systemic disease
* Acute coronary syndrome \> 2 months

Primary outcomes:
measure: Exercise test
timeFrame: 6 months
Secondary outcomes:
measure: Clinical evaluation
timeFrame: 6 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet University Hospital Copenhagen
Study officials:
affiliation: Department of Cardiology, Rigshospitalet
name: Jens Kastrup, MD Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Qayyum AA, Mathiasen AB, Helqvist S, Jorgensen E, Haack-Sorensen M, Ekblond A, Kastrup J. Autologous adipose-derived stromal cell treatment for patients with refractory angina (MyStromalCell Trial): 3-years follow-up results. J Transl Med. 2019 Nov 12;17(1):360. doi: 10.1186/s12967-019-2110-1.
citation: Qayyum AA, Mathiasen AB, Mygind ND, Kuhl JT, Jorgensen E, Helqvist S, Elberg JJ, Kofoed KF, Vejlstrup NG, Fischer-Nielsen A, Haack-Sorensen M, Ekblond A, Kastrup J. Adipose-Derived Stromal Cells for Treatment of Patients with Chronic Ischemic Heart Disease (MyStromalCell Trial): A Randomized Placebo-Controlled Study. Stem Cells Int. 2017;2017:5237063. doi: 10.1155/2017/5237063. Epub 2017 Dec 3.