CSCC_ASC Therapy in Patients With Severe Heart Failure

NCT02387723 | Completed Phase 1 DMC

• 1 other identifier: CSCC_ASC1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The present aim is to perform at small clinical safety trial in heart failure patients with allogeneic adipose tissue derived mesenchymal stem cells.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Safety: Number of patients with serious adverse events and development of tissue antibodies towards donor cells

  Registration of number of patients with serious adverse events and development of tissue antibodies towards donor cells used for treatment in a 6 months follow-up period

  6 months

Secondary Outcomes (1)

• Cardial efficacy: left ventricle end-systolic volume (LVESV, ml), left ventricular ejection fraction (LVEF, %), end-diastolic volume (ml) and end-systolic mass (g)

  6 months

Study Arms (1)

Stem cell therapy

EXPERIMENTAL

Treatment with direct intra-myocardial Injection of 100 million allogeneic adipose derived stem cells (CSCC\_ASC) into the heart

Biological: Allogeneic adipose derived stem cells (CSCC_ASC)

Interventions

Allogeneic adipose derived stem cells (CSCC_ASC) BIOLOGICAL

Culture expanded allogeneic adipose derive stem cells (CSCC\_ASC)

Stem cell therapy

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 80 years of age
• Signed informed consent
• Chronic stable IHD
• HF (NYHA II-III)
• LVEF ≤45%
• Maximal tolerable angina and heart failure medication
• No option for percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
• Patients cannot be included until six months after implantation of a cardiac resynchronisation therapy device

You may not qualify if:

• Heart Failure (NYHA I or IV)
• Other revascularisation treatment within four months of treatment
• Moderate to severe valvular disease or valvular disease with option for valvular surgery
• Diminished functional capacity for other reasons such as: coronary obstructive pulmonary disease (COPD) with forced expiratory volume (FEV) \<1 L/min, moderate to severe claudication or morbid obesity
• Clinical significant anaemia, leukopenia, leukocytosis or thrombocytopenia
• Clinically significant abnormal prothrombin or partial thromboplastin time or anticoagulation treatment that cannot be paused during cell injections
• Patients with reduced immune response or treated with immunosuppressive medication
• Pregnant women
• Other experimental treatment within four weeks of baseline tests
• Participation in another intervention trial

Sponsors & Collaborators

• JKastrup: lead

Study Sites (1)

2014 Department of Cardiology, The Heart Centre, University Hospital Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Jens Kastrup, Professor MD

  Rigshospitalet, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Chief Physician

Study Record Dates

• First Submitted: December 29, 2014
• First Posted: March 13, 2015
• Study Start: December 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 2, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)