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Congestive Heart Failure Surgical Treatmment With Autologous Stem Cell Therapy

Primary Purpose

Congestive Heart Failure

Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
intramiocardiac autograft of autologous stem cells
Sponsored by
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

  • Age >18 y/o
  • CHF with EF > 35%
  • Bilirubinemia, serum transaminase> 2.5 times normal max level
  • Creatininemia > 2.5 times max level
  • NYHA Class > 3
  • Negative pregnancy test (for women in fertile age)

Exclusion criteria

  • Impossibility to harvest the bone marrow
  • Pregnancy or breast-feeding
  • History of malignant neoplasia in the 5-year period before the study (save for in-situ carcinoma of the cervix treated successfully and skin tumors - not melanomas)
  • Incapability or unwillingness to comply with the envisaged treatment protocol, follow-up, or tests.

Sites / Locations

  • IsmettRecruiting

Outcomes

Primary Outcome Measures

Primary target: determine the safety of introducing CD 34+ autologous progenitor cells (centrally grafted or mobilized in peripheral blood) in the myocardium of ischemic cardiac disease patients.

Secondary Outcome Measures

Secondary target: determine clinical effects of grafted cells on remodeling pathology.

Full Information

First Posted
May 31, 2007
Last Updated
May 31, 2007
Sponsor
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
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1. Study Identification

Unique Protocol Identification Number
NCT00480961
Brief Title
Congestive Heart Failure Surgical Treatmment With Autologous Stem Cell Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Unknown status
Study Start Date
May 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This research study was designed to test the safety and effectiveness of autologous stem cell graft in the myocardium of patients with refractory Congestive Heart Failure (CHF) with ischemic etiology. Cellular implantation will take place during off-pump revascularization surgery or during an ad hoc procedure using a mini-thoracotomy access.
Detailed Description
Primary target: determine the safety of introducing CD 34+ autologous progenitor cells (centrally grafted or mobilized in peripheral blood) in the myocardium of ischemic cardiac disease patients. Secondary target: determine clinical effects of grafted cells on remodeling pathology.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
intramiocardiac autograft of autologous stem cells
Primary Outcome Measure Information:
Title
Primary target: determine the safety of introducing CD 34+ autologous progenitor cells (centrally grafted or mobilized in peripheral blood) in the myocardium of ischemic cardiac disease patients.
Time Frame
1 YEAR
Secondary Outcome Measure Information:
Title
Secondary target: determine clinical effects of grafted cells on remodeling pathology.
Time Frame
1 YEAR

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Age >18 y/o CHF with EF > 35% Bilirubinemia, serum transaminase> 2.5 times normal max level Creatininemia > 2.5 times max level NYHA Class > 3 Negative pregnancy test (for women in fertile age) Exclusion criteria Impossibility to harvest the bone marrow Pregnancy or breast-feeding History of malignant neoplasia in the 5-year period before the study (save for in-situ carcinoma of the cervix treated successfully and skin tumors - not melanomas) Incapability or unwillingness to comply with the envisaged treatment protocol, follow-up, or tests.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
cesare scardulla, MD
Phone
0912192284
Email
cscardulla@ISMETT.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CESARE SCARDULLA, md
Organizational Affiliation
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ismett
City
Palermo
State/Province
PA
ZIP/Postal Code
90127
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CESARE SCARDULLA, md

12. IPD Sharing Statement

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Congestive Heart Failure Surgical Treatmment With Autologous Stem Cell Therapy

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