Study Protocol of Intramyocardial Injection of Autologous Bone Marrow Stem Cells for Refractory Angina

Summary

Therapeutic neovascularization is an innovative strategy for cardiac tissue recovery due to chronic, intense ischemia. Thus stem cell therapy has become a promising procedure for the large number of patients with refractory angina due to coronary disease, despite of the use of multiple anti-angina medications, remain severely symptomatic with disabling angina.

Stem cell therapy using autologous cells from the patient's bone marrow, has been shown to be safe and associated with improved myocardial perfusion, reducing the symptoms of advanced coronary artery disease and increasing the functional capacity of patients whose therapeutic armamentarium available today has been exhausted.

The study hypothesis was that the infusion of autologous mononuclear cells derived from the patient's bone marrow and delivered via intramyocardial injection in patients with refractory angina and normal or slightly depressed ventricular function, promote improvement in the anginal symptoms and myocardial perfusion by the inducing neoangiogenesis.

Conditions

• Refractory Angina

Interventions

PROCEDURE

Local sedation

All subjects enrolled in the study underwent local sedation for bone marrow aspiration.

PROCEDURE

Bone Marrow Aspiration

All subjects enrolled in the study underwent bone marrow aspiration after they had been anesthetized from the posterior iliac crest. The sample was aspirated into a series of sterile syringes and brought to the cell processing room/laboratory. The processing was in accordance to the Standard Operating Procedure developed observing Good Practice Guidelines.

PROCEDURE

Minithoracotomy

The surgical procedure used as cardiac access route was the left anterolateral thoracotomy or left anterior minithoracotomy, depending on the segment of the left ventricle to be treated, allowing the good access to the viable myocardial areas.

BIOLOGICAL

Autologous bone marrow mononuclear cells infusion

Once the subject had his or her chest opened and the coronary anatomy reviewed by examination of the pre-operatory nuclear scan to define the area of ischemia, the surgeon drew up the cells into a series of syringes and injected the entire contents of the cell preparation in a series of injections directly into the myocardium.

Sponsors & Collaborators

• Cryopraxis Criobiologia Ltda.

  collaborator INDUSTRY

• Federal University of São Paulo

  collaborator OTHER

• University of South Florida

  collaborator OTHER

• CellPraxis Bioengenharia Ltda.

  lead INDUSTRY

Principal Investigators

• Nelson A Hossne Junior, MD, PhD · Federal University of São Paulo

• Enio Buffolo, MD, PhD · Federal University of São Paulo

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-07-31

Primary Completion

2011-11-30

Completion

2012-12-31

Countries

• Brazil

Study Locations