Briefing Document

 

Biological Response Modifiers Committee Meeting # 37

 

 

 

Cellular Products for the Treatment of Cardiac Disease

 

 

March 18-19, 2004

 

INTRODUCTION   1

MEETING GOALS   1

BACKGROUND   2

General: 2

Regulatory: 3

MANUFACTURING INFORMATION   4

Cellular Products Manufactured Without in vitro Culture Methodology   4

Cell Collection   5

BMSC & PBSC Processing   5

Cellular Products Manufactured With in vitro Culture Methodology   5

Myoblast Collection and Processing   6

Mesenchymal Stem Cell (MSC) Collection and Processing   6

Unique Issues with Cellular Products  6

Microbiological Safety   6

Product Formulation   7

Product Characterization   7

Manufacturing Questions  7

PRECLINICAL STUDIES   8

Cellular Products Manufactured Without in vitro Culture Methodology   9

Cellular Products Manufactured With in vitro Culture Methodology   9

Preclinical Summary   11

Preclinical Questions: 11

INVESTIGATIONAL CATHETERS FOR DELIVERY OF CELLULAR PRODUCTS TO THE HEART   12

Infusion of Cellular Products into Coronary Arteries: 12

Intramyocardial Injection of Cell Suspensions through Cardiac Catheters: 15

Device Question: 18

CLINICAL STUDIES   18

Cellular Products Derived from Bone Marrow: 18

Overview: 18

Delivery Methods: 19

Outcomes: 19

Cells Derived from Skeletal Muscle: 20

Overview: 20

Administration: 21

Outcomes: 21

Clinical Questions: 22

List of Questions: 24

Manufacturing: 24

Preclinical: 24

Device: 25

Clinical: 26

Attachments: 27

Cited References  28