Study Protocol of Intramyocardial Injection of Autologous Bone Marrow Stem Cells for Refractory Angina (ReACT)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01966042 |
Recruitment Status :
Completed
First Posted : October 21, 2013
Results First Posted : June 3, 2014
Last Update Posted : June 3, 2014
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Refractory Angina |
Interventions |
Procedure: Local sedation Procedure: Bone Marrow Aspiration Procedure: Minithoracotomy Biological: Autologous bone marrow mononuclear cells infusion |
Enrollment | 13 |
Recruitment Details | Refractory angina patients routinely undergoing treatment at the São Paulo Hospital, in São Paulo, Brazil, a referral tertiary Federal University Hospital for coronary heart disease, were included in the study. The study protocol (ReACT™) was approved by the local and national ethical committee and all patients provided written informed consent. |
Pre-assignment Details | Refractory angina patients were defined as those with functional class IV (angina at rest) according to the Canadian Cardiovascular Society Angina Classification (CCSAC) despite maximum medical therapy, not suitable for conventional myocardial revascularization and with viable myocardium identification. |
Arm/Group Title | Cell Therapy |
---|---|
![]() |
All subjects enrolled in the study underwent bone marrow aspiration and autologous bone marrow mononuclear cells infusion. Local sedation: All subjects enrolled underwent local sedation for bone marrow aspiration. Bone Marrow Aspiration: All subjects enrolled underwent bone marrow aspiration after anesthesia from the posterior iliac crest. The sample was aspirated into sterile syringes and brought to the cell processing laboratory. The processing was in accordance to the Standard Operating Procedure developed observing Good Practice Guidelines. Minithoracotomy: The cardiac access route was the left anterolateral thoracotomy or left anterior minithoracotomy, depending on the segment of the left ventricle to be treated. Autologous bone marrow mononuclear cells infusion: Once the subject had his or her chest opened, the surgeon drew up the cells into syringes and injected the entire contents of the cell preparation in a series of injections directly into the myocardium. |
Period Title: Overall Study | |
Started | 13 |
Completed | 11 |
Not Completed | 2 |
Reason Not Completed | |
Death | 2 |
Arm/Group Title | Cell Therapy | |
---|---|---|
![]() |
All subjects enrolled in the study underwent bone marrow aspiration and infusion of autologous bone marrow mononuclear cells. Local sedation: All subjects enrolled in the study underwent local sedation for bone marrow aspiration. Bone Marrow Aspiration: All subjects enrolled in the study underwent bone marrow aspiration after anesthesia. Minithoracotomy: The 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. 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. |
|
Overall Number of Baseline Participants | 13 | |
![]() |
One patient died from cardiogenic shock due to anterior myocardial infarction after 5 months of follow-up. One patient, after 47.3 months of ReACT's procedure, migrated to CCSAC 4 and met inclusion criteria again. This patient was submitted to a new ReACT's procedure.
|
|
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||
Number Analyzed | 13 participants | |
64 (8) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||
Number Analyzed | 13 participants | |
Female |
3 23.1%
|
|
Male |
10 76.9%
|
|
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
||
Brazil | Number Analyzed | 13 participants |
13 |
Name/Title: | Dr. Nelson Americo Hossne Junior |
Organization: | Federal University of Sao Paulo (UNIFESP) |
Phone: | +55 11 5571-2719 |
EMail: | nelson.hossne@gmail.com |
Responsible Party: | CellPraxis Bioengenharia Ltda. |
ClinicalTrials.gov Identifier: | NCT01966042 |
Other Study ID Numbers: |
Cell 0314/05 0314/05 ( Other Identifier: CEP ) |
First Submitted: | October 14, 2013 |
First Posted: | October 21, 2013 |
Results First Submitted: | December 27, 2013 |
Results First Posted: | June 3, 2014 |
Last Update Posted: | June 3, 2014 |