MesenchYmal STROMAL CELL Therapy in Patients With Chronic Myocardial Ischemia (MyStromalCell Trial)

NCT ID: NCT01449032

Last Updated: 2014-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2014-01-31

Brief Summary

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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

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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.

Conditions

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Chronic Ischemic Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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MSC

Adipose derived stem cells

Group Type ACTIVE_COMPARATOR

MSC

Intervention Type BIOLOGICAL

No of cells after culture expansion

Saline

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type BIOLOGICAL

3 cc saline

Interventions

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MSC

No of cells after culture expansion

Intervention Type BIOLOGICAL

Saline

3 cc saline

Intervention Type BIOLOGICAL

Other Intervention Names

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Adipose derived stem cells Mesenchymal stromal cells Mesenchymal stem cells

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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JKastrup

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jens Kastrup, MD Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Rigshospitalet

Locations

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Rigshospitalet University Hospital Copenhagen

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 31711513 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29333165 (View on PubMed)

Other Identifiers

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MyStromalCell

Identifier Type: -

Identifier Source: org_study_id

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