Stem Cell Processing (Stem Cells in Clinical Applications)

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Recent studies have shown that allogeneic MSCs can perform better
immunomodulation than autologous MSCs. These results triggered the use of allo-
geneic MSCs in clinical applications. Commercialized MSC-based products have
been developed and approved as stem cell drugs in some countries (Table 6.2 ).
Osteocel (NuVasive), Trinity (Orthofi x), and LiquidGen (Skye Orthobiologics) use
allogeneic MSCs as the main component for bone regeneration and reduction of
infl ammation. MSC-based products have also been approved in Canada and Korea
for certain diseases. Cartistem is stem cell drug containing umbilical cord blood-
derived MSCs, which was approved in Korea as a drug for osteoarthritis. In 2012,
Prochymal (Osiris Therapeutics), an allogeneic MSC-based product, was approved
in Canada for graft-versus-host disease treatment. To date (2015), there are nine
commercialized MSC-based products approved worldwide. Interestingly, most of
them are allogeneic MSC-based products (Table 6.2 ).
Although MSCs are widely used in clinical treatments, there still are some issues
related to the quality and safety of MSCs (Fig. 6.2 ). To maintain MSC quality and
reduce the risks after MSC transplantation, MSCs should be produced in accor-
dance with good manufacturing practice (GMP) guidelines.

Table 6.2 MSC products approved for clinical use

Names of

products

Component

of stem

cells Indications

Kind of

transplan

tation Company Country

Cartistem MSCs from

UCB

OA Allo Medipost Korea

MPC MSCs N/A Allo Mesoblast Australia

Cupistem MSCs from

AT

Fistulizing

Crohn’s

disease

Auto Anterogen Korea

Prochymal MSCs from

BM

GVHD Allo Osiris

Therapeutics

Canada

AlloStem MSCs from

BM

OA Allo AlloSource America

Hearticellgram-

AMI

MSCs from

BM

Acute

myocardial

infarction

Auto FCB

Pharmicell

Korea

Osteocel Plus MSCs from

BM

OA Allo NuVasive America

Trinity Evolution MSCs from

BM

OA Allo Orthofi x America

CardioRel MSCs from

BM

Acute

myocardial

infarction

Auto Reliance Life

Sciences

India

MSCs mesenchymal stem cells, BM bone marrow, UCB umbilical cord blood, Auto autologous,
Allo allogeneic, OA osteoarthritis

6 Production of Clinical-Grade Mesenchymal Stem Cells