Global Cell Therapy Market Outlook, Patent & Clinical Trials Insight 2028

August 2021 | 1800 pages | ID: G2A21FD2CB86EN
Kuick Research

Abstracts

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'Global Cell Therapy Market Outlook, Patent & Clinical Trials Insight 2028' Report Highlights:

• Global Cell Therapy Market Opportunity: > USD 45 Billion By 2028
• Cell Therapy Clinical Trial Insight by Indication, Company and Country
• Insight On More than 1600 Cell Therapies in Clinical Trials
• Clinical & Commercial Insight On 32 Cell Therapies Available in Market
• Dosage & Pricing Insight By Country & Region
• COVID-19 Impact Analysis on Global market & Clinical Trials
• Price & Product Insight By Region/Country

In last few years, cellular therapies have gained a considerable momentum in the management of wide range of diseases including cancer, hematological malignancies, autoimmune disorders, and damaged tissue. The cellular therapies mainly consists of hematopoietic stem cell transformation (HSCT), adoptive immune therapy for cancer, gene therapy for management of inherited deficiencies and bone marrow stromal cell (BMSC) therapy for the treatment of ischemic heart diseases. Researchers are currently making huge investments in the development of such effective and safe treatment as an alternative to conventional therapies.

Currently, cell therapy is one of the most exciting fields in translational medicine as it can effectively alleviate the underlying cause of genetic and acquired disease. The cell therapy works by restoring or altering cells and it functions by cultivating or manipulating cells outside the body before they are again injected into patient’s body. The cell therapies consist of all aspects of cellular immunotherapies, cellular medications, and other therapies which include cells from donor and recipients for cell therapies. Continuous research and development in cell therapy has accelerated at a fast rate, with the increasing number of products entering clinical trials and development.

The entrance of chimeric antigen T-cell therapy for the management of cancer has also driven the growth of market. Currently, two CAR T-cell products have been approved for the management of cancer which has shown high adoption rates in the market. Apart from T-cells, researchers are also utilizing NK cells as alternative vehicles for their CAR engineering, given their unique biological features and established safety profile in the allogeneic setting. In addition to this, other immune effector cells including gamma-delta T cells or macrophages are attracting interest and may be added to the repertoire of engineered cell therapies against cancer.

The global cell therapy market was valued at less than US$ 20 Billion in 2020 and is expected to surpass US$ 45 Billion by 2028. The market is mainly driven by the large number of clinical studies of cell based therapies which can be attributed to the presence of government and private funding agencies that are constantly offering grants to support projects across various stages of clinical trials. Furthermore, the need of better and targeted therapies in the management of diseases such as cancer and cardiovascular diseases has also resulted in overall increase in research and development activities, thus boosting the growth of market.

North America is expected to hold the largest share in the market during the forecast period. The large share of the region is mainly due to the presence of substantial number of pharmaceutical companies and research centers. The major key players in cell therapy market are Fibrocell Science, JCR Pharmaceuticals, Pharmicell, Osiris Therapeutics, Medipost, Vericel Corporation, Anterogen, Kolon TissueGene, Stemedica Cell Technologies, and AlloCure. In addition to this, Asia Pacific is expected to witness high CAGR rates due to rising investment by developers and consumers in educating themselves for advanced targeted therapies. Furthermore, the rise in healthcare expenditure and developing guidelines are expected to propel the growth of market in this region.

Contents

1. WHAT IS CELL THERAPY?

1.1 Introduction
1.2 History & Evolution of Cell Therapy
1.3 Cell Therapy Classification

2. MECHANISM OF THERAPEUTIC ACTION IN CELL THERAPY

3. EMERGENCE OF PERSONALIZED CELL THERAPY

3.1 Overview of Personalized Cell Therapy
3.2 Personalized Cell Therapy Using Epigenetic Tools
3.3 Personalized Cell Therapy through Mesenchymal Stem Cells
3.4 Treatment of Parkinson’s Disease through IPSCs
3.5 Case Study: Personalized Cell Therapy for Pulpitis Using Autologous Dental Pulp
Stem Cells & Leukocyte Platelet Rich Fibrin

4. CELL THERAPY APPLICATION BY THERAPEUTIC AREAS

4.1 Cardiovascular Disease
4.2 Neurological Disorders
4.3 Inflammatory Diseases
4.4 Diabetes

5. ROLE OF CELL THERAPY IN CANCER THERAPEUTICS

6. GLOBAL CELL THERAPY CLINICAL TRIALS 2021 -2028

6.1 By Phase
6.2 By Country/Region
6.3 By Company
6.4 By Indication
6.5 By Patient Segment
6.6 By Route Of Administration

7. IMPACT OF COVID-19 ON CELL THERAPY RESEARCH LANDSCAPE

8. GLOBAL CELL THERAPIES CLINICAL PIPELINE BY COMPANY, INDICATION & PHASE

8.1 Unknown
8.2 Research
8.3 Preclinical
8.4 Clinical
8.5 Phase-0
8.6 Phase-I
8.7 Phase-I/II
8.8 Phase-II
8.9 Phase-II/III
8.10 Phase-III
8.11 Preregistration
8.12 Registered

9. GLOBAL CELL THERAPY MARKET OUTLOOK

9.1 Current Market Scenario
9.2 Cell Therapy Market by Cell Source

10. US - CELL THERAPY DOSAGE & COST ANALYSIS

10.1 Allocord
10.2 Laviv
10.3 Maci
10.4 Clevecord
10.5 Hemacord
10.6 Ducord
10.7 Provenge
10.8 HPC, Cord Blood (Clinimmune Labs, University of Colorado Cord Blood Bank)
10.9 HPC, Cord Blood (LifeSouth Community Blood Centers, Inc)
10.10 HPC, Cord Blood (Bloodworks)
10.11 HPC, Cord Blood (MD Anderson Cord Blood Bank)
10.12 Gintuit
10.13 Kymriah*
10.14 Yescarta*
10.15 Carticel
10.16 Abecma (Idecabtagene Vicleucel)
10.17 Breyanzi (Lisocabtagene Maraleucel)

11. SOUTH KOREA - CELL THERAPY DOSAGE & COST ANALYSIS

11.1 Cartistem
11.2 Chondron
11.3 KeraHeal
11.4 Cellgram
11.5 Cure Skin Injection

12. EUROPE - CELL THERAPY DOSAGE & COST ANALYSIS

12.1 Holoclar (Europe)
12.2 Yescarta (EU)
12.3 Kymriah (EU)
12.4 Alofisel (EU)
12.5 Strimvelis (EU)
12.6 Urocell (Germany/Switzerland/Belgium)
12.7 CellSpray (Belgium)

13. JAPAN - CELL THERAPY DOSAGE & COST ANALYSIS

13.1 Temcell HS (Japan)
13.2 HeartSheet (Japan)
13.3 Stemirac

14. SOUTH KOREA - CELL THERAPY DOSAGE & COST ANALYSIS

14.1 Neuronata-R lenzumestrocel (South Korea)
14.2 Invossa-K (South Korea)
14.3 Adipocell / Cupistem/ Queencell (Korea)

15. REST OF WORLD - CELL THERAPY DOSAGE & COST ANALYSIS

15.1 Chondrocytes-T-Ortho-ACI (Australia)
15.2 Prochymal (Canada/New Zealand)
15.3 Apceden (India)
15.4 BioCartII (Israel)
15.5 Nucel
15.6 CureXcell (Israel)

16. GLOBAL CELL THERAPY MARKET SCENARIO

16.1 US
16.2 South Korea
16.3 Europe
16.4 Japan
16.5 China
16.6 Rest of the World

17. CELL THERAPY RESEARCH INSIGHTS AT UNIVERSITY LEVEL

17.1 Novel Autologous CAR-T Cell Therapy in Multiple Myeloma
17.2 Encouraging Cell Therapy Results with Cocoon Automated Platforms
17.3 CNCT19 Received Breakthrough Designation in China
17.4 Positive Results of MultiStem for ARDS in One-Bridge Study
17.5 MB-102 Initiated Phase-I/II Clinical Trial
17.6 G-NK Cells in Combination with Monoclonal Antibodies for Multiple Myeloma
17.7 Phase-III Trial Results of Omidubicel in Various Cancers
17.8 Novel Cell Therapy Combination shows Potential in NSCLC

18. STRATEGIC ALLIANCES FOR PROMOTING CELL THERAPY RESEARCH

18.1 Kite Pharma & Appia Bio New Collaboration for Allogeneic Cell Therapy
18.2 New Strategic Collaboration for Novel Mitochondrial Cell Therapy Programs
18.3 Lilly & Sigilon Therapeutics to Develop Cell Therapies for Diabetes
18.4 Artiva Biotherapeutics Expand its Facilities in San Diego
18.5 Orion & Blood Service Launch Collaboration for Cancer Cell Therapy
18.6 Bayer & Atara Biotherapeutics Alliance for Cell Therapies in Solid Tumors
18.7 Tata Memorial Hospital & IIT Partnership for First CAR-T Cell Therapy in India
18.8 Mustang Bio Partnership with Mayo Clinic on Novel Cell Therapy
18.9 Cellares Partner with Poseida Therapeutics to Advance Cell Therapy
Manufacturing
18.10 Joint Venture by Orgenesis & Cure Therapeutics for Cell & Gene Therapies

19. TREG CELLS – THE NEXT STEP TO ADVANCE CELL THERAPY

19.1 Introduction to Treg Cell
19.2 Isolation & Expansion of Treg Cell
19.3 Mechanism of Action
19.4 Clinical Trials of Treg Cell Therapy
19.5 Treg Cell Therapy for the Treatment of Autoinflammatory & Autoimmune Diseases
19.6 Future Prospects of Treg Cell Therapy

20. GLOBAL CELL THERAPY MARKET FUTURE PROSPECTS

21. MARKETED CELL THERAPIES CLINICAL INSIGHT BY COMPANY & INDICATION

21.1 Abecma
21.2 Yescarta
21.3 Breyanzi
21.4 NEURONATA-R
21.5 Provenge
21.6 RYONCIL / Prochymal
21.7 Kymriah
21.8 Chondrotransplant DISC
21.9 MACI
21.10 Carticel
21.11 STEMIRAC
21.12 HeartSheet
21.13 Strimvelis
21.14 Cartistem
21.15 Adipocell (Anterogen)
21.16 Alofisel
21.17 Zalmoxis
21.18 Cellgram
21.19 INVOSSA-K inj
21.20 APCEDEN for RCC
21.21 Laviv
21.22 BioCart
21.23 Gintuit
21.24 Holoclar
21.25 MyoCell
21.26 CellSpray
21.27 CureXcell
21.28 CHONDRON
21.29 NuCel
21.30 Dendritic Cell-Activated Cytokine-Induced killer Cells - Shanghai Jia Fu Medical
21.31 Urocell
21.32 Autologous chondrocyte implant – TETEC

22. COMPETITIVE LANDSCAPE

22.1 Athersys Inc.
22.2 Baxter Healthcare Corporation
22.3 Bone Therapeutics
22.4 Celgene Corporation
22.5 Cell Medica
22.6 Cellerant Therapeutics
22.7 FibrocellScinence
22.8 Genzyme Corporation
22.9 Green Cross Cell
22.10 Histogenics Corporation
22.11 Intrexon Corporation
22.12 Intercytex
22.13 ISTO Biologics
22.14 Macrocure
22.15 Mesoblast
22.16 Molmed
22.17 Nuo Therapeutics Inc
22.18 OmniCyte
22.19 Opexa Therapeutics
22.20 Organogenesis
22.21 Pharmicell
22.22 TCA Cellular Therapy
22.23 Stem Cell Inc.
22.24 Teva Pharmaceuticals
22.25 Tigenix
22.26 Vericel Corporation

List Of Figures

LIST OF FIGURES

Figure 1-1: Cell Therapy Pathway
Figure 1-2: Evolution of Cell Therapy
Figure 1-3: Types of Cell Therapy
Figure 1-4: Steps in Allogeneic Cell Therapy
Figure 1-5: Steps in Autologous Cell Therapy
Figure 1-6: Steps in the Derivation of Human Embryonic Stem Cells
Figure 1-7: Cardinal Neural Stem Cell Properties
Figure 1-8: Mesenchymal Stem Cells Therapy Process
Figure 2-1: Cell Therapy Mechanism
Figure 3-1: Advantages of Personalized Cell Therapy
Figure 3-2: Mesenchymal Stem Cells (MSCs) in Autism Spectrum Disorder (ASD) Treatment
Figure 3-3: Steps of iPSC Transplantation
Figure 4-1: Global - Mortality Caused by Non Communicable Disease (%)
Figure 4-2: Cell Therapy for Cardiovascular Disease
Figure 4-3: Overview of Stem Cell Therapy in Cardiovascular Disease
Figure 4-4: Cell Therapy in Neurological Disorders
Figure 4-5: Cell Therapy in Treatment of Alzheimer's disease
Figure 4-6: Cell Therapy in Diabetes
Figure 6-1: Global - Cell Therapies Clinical Pipeline by Phase (%), 2021 till 2028
Figure 6-2: Global - Cell Therapies Clinical Pipeline by Phase (Number), 2021 till 2028
Figure 6-3: Global - Cell Therapies Clinical Pipeline by Region (Number), 2021 till 2028
Figure 6-4: Global - Cell Therapies Clinical Pipeline by Company (Number), 2021 till 2028
Figure 6-5: Global - Cell Therapies Clinical Pipeline by Indication (Number), 2021 till 2028
Figure 6-6: Global - Cell Therapies Clinical Pipeline by Patient Segment (Number), 2021 till 2028
Figure 6-7: Global - Cell Therapies Clinical Pipeline by Route Of Administration (Number), 2021 till 2028
Figure 9-1: Cell Therapy- The Final Therapeutic Pillar of Healthcare
Figure 9-2: Global - Cell Therapy Market (US$ Billion), 2020 - 2028
Figure 9-3: Process for Conventional Drug Delivery
Figure 9-4: Process for Induced Pluripotent Stem Cell Based Drug Delivery
Figure 9-5: Global- Induced Pluripotent Stem Cell Therapy Market (US$ Billion), 2020 - 2028
Figure 9-6: Steps involved in Bone Marrow Transplant
Figure 10-1: US – Allocord Infusion per Hour (Milliliters), Adult & Children
Figure 10-2: Allocord – Composition of Single Unit of Suspension for Injection (Million Cells)
Figure 10-3: Laviv – FDA Approval & Patent Expiration Year
Figure 10-4: Laviv – Cost of Single Treatment Cycle & Full Treatment Cost (US$), August’2021
Figure 10-5: MACI – Mixed Cell Populations for Tissue Repair & Separation Technique Related Patent Issue & Expiration Year
Figure 10-6: MACI – Administration Related Patent Issue & Expiration Year
Figure 10-7: MACI – Method of Manufacturing Related Patent Issue & Expiration Year
Figure 10-8: MACI – Minumum & Maximum Cost of Single Sheet of 500,9000 Cells/cm2 (US$), August’2021
Figure 10-9: MACI – Cost for Treatment of Fractures & Cartilage Injury (US$), May’2020
Figure 10-10: MACI – Cost for Treatment of Fractures & Cartilage Injury (US$), May’2020
Figure 10-11: US – Clevecord Dosage of Nucleated Cells per Killogram (Million) & Average Cost (US$)
Figure 10-12: Hemacord – Composition of Single Unit of Suspension for Injection (Million Cells)
Figure 10-13: Ducord – Composition of Single Unit of Suspension for Injection (Million Cells)
Figure 10-14: Provenge – Patent Issue & Expiration Year
Figure 10-15: Provenge – Price of 250ml Supply & Price per ml (US$), August’2021
Figure 10-16: Provenge – Price of Single Treatment Cycle & Price for Full Treatment (US$), August’2021
Figure 10-17: HPC Cord Blood (Clinimmune Labs) – Composition of Single Unit of Suspension for Injection (Million Cells)
Figure 10-18: Kymriah – FDA Approval Year by Indication
Figure 10-19: Kymriah – Number of Patents by Region
Figure 10-20: Kymriah – Number of US Patents by Nature of Patent
Figure 10-21: US – Kymriah Average Dosage of CAR positive viable T cells (Paediatric & Adults), August 2017
Figure 10-22: Kymriah – Cost of Intravenous Suspension & Additional Expenditure (US$), August’2021
Figure 10-23: Kymriah – Minimum & Maximum Dose for Patients with Less than 50Kg Weight for ALL Management (Million Cells/ Kg), May’2020
Figure 10-24: Kymriah – Minimum & Maximum Dose for Management of Large B-Cell Lymphoma (Million Cells/ Kg), May’2020
Figure 10-25: Kymriah - Annual Sales Value (US$ Million), 2017 - 2019
Figure 10-26: Global - Kymriah Quarterly Sales Value (US$ Million), 2019
Figure 10-27: Global - Kymriah Quarterly Sales Value (US$ Million), 2020
Figure 10-28: Global - Kymriah Half Yearly Sales Value (US$ Million), Q1 & Q2, 2020
Figure 10-29: Yescarta – FDA Approval & US Patent Expiration Year
Figure 10-30: US – Yescarta Target Dose vs Maximum Dose of CAR-positive viable T cells, October 2017
Figure 10-31: Yescarta – Cost of Intravenous Suspension & Additional Expenditure (US$), August’2021
Figure 10-32: Yescarta – Dose for Average Human & Maximum Dose (Million Cells), August’2021
Figure 10-33: Yescarta - Annual Sales Value (US$ Million), 2017 - 2020
Figure 10-34: Yescarta - Annual Sales Value by Region (US$ Million), 2019
Figure 10-35: Yescarta – Annual Sales Value by Region (%), 2019
Figure 10-36: Yescarta - Annual Sales Value by Region (US$ Million), 2020
Figure 10-37: Yescarta - Annual Sales Value by Region (US$ Million), 2020
Figure 10-38: Global - Yescarta Quarterly Sales Value (US$ Million), 2018 & 2019
Figure 10-39: Global - Yescarta Quarterly Sales Value (US$ Million), 2020
Figure 10-40: US - Yescarta Quarterly Sales Value (US$ Million), 2020
Figure 10-41: Europe - Yescarta Quarterly Sales Value (US$ Million), 2020
Figure 10-42: Global - Yescarta Half Yearly Sales Value (US$ Million), Q1 & Q2, 2021
Figure 10-43: US - Yescarta Half Yearly Sales Value (US$ Million), Q1 & Q2, 2021
Figure 10-44: Europe - Yescarta Half Yearly Sales Value (US$ Million), Q1 & Q2, 2021
Figure 10-45: Carticel - FDA Approval & Patent Expiration Year
Figure 10-46: Carticel – Minumum & Maximum Cost of Single Vial of 12 Million Cells/0.4ml (US$), August’2021
Figure 10-47: US – Carticel Minimum & Maximum Cost (US$), 2018
Figure 10-48: Abecma – Minimum & Maximum Dosage of CAR positive viable T Cells (Million Cells), August’2021
Figure 10-49: Breyanzi – Minimum & Maximum Dosage of CAR positive viable T Cells (Million Cells), August’2021
Figure 11-1: Cartistem – Average Cost of Regenerative & Additional Treatment (US$), August’2021
Figure 11-2: Cartistem – Annual Sales Value (KRW/US$ Million), 2012, 2019 & 2020
Figure 11-3: Chondron – Average Cost of Knee Cartilage Defect Treatment (KRW/US$), May’2020
Figure 11-4: South Korea - KeraHeal vs KeraHeal-Allo Dosage form (Miililitres Cell Suspension)
Figure 11-5: Cellgram – Average Cost of Intravenous Suspension (KRW/US$), May’2020
Figure 12-1: Holoclar – Cost of Single & Both Eyes Treatment (GBP/US$), May’2020
Figure 12-2: Holoclar – Recommended Minimum & Maximum Dose (Cells/cm2 of Cornea Surface), May’2020
Figure 12-3: Yescarta – FDA Approval, EU Approval & US Patent Expiration Year
Figure 12-4: Yescarta – Cost of Intravenous Suspension & Additional Expenditure (EUR/US$), August’2021
Figure 12-5: Yescarta – Dose for Average Human & Maximum Dose (Million Cells)
Figure 12-6: Yescarta - Annual Sales Value (US$ Million), 2017 - 2020
Figure 12-7: Yescarta - Annual Sales Value by Region (US$ Million), 2019
Figure 12-8: Yescarta – Annual Sales Value by Region (%), 2019
Figure 12-9: Yescarta - Annual Sales Value by Region (US$ Million), 2020
Figure 12-10: Yescarta - Annual Sales Value by Region (US$ Million), 2020
Figure 12-11: Global - Yescarta Quarterly Sales Value (US$ Million), 2018 & 2019
Figure 12-12: Global - Yescarta Quarterly Sales Value (US$ Million), 2020
Figure 12-13: US - Yescarta Quarterly Sales Value (US$ Million), 2020
Figure 12-14: Europe - Yescarta Quarterly Sales Value (US$ Million), 2020
Figure 12-15: Global - Yescarta Half Yearly Sales Value (US$ Million), Q1 & Q2, 2021
Figure 12-16: US - Yescarta Half Yearly Sales Value (US$ Million), Q1 & Q2, 2021
Figure 12-17: Europe - Yescarta Half Yearly Sales Value (US$ Million), Q1 & Q2, 2021
Figure 12-18: Kymriah – FDA Approval Year by Region
Figure 12-19: Kymriah – Number of Patents by Region
Figure 12-20: Kymriah – Cost of Intravenous Suspension & Additional Expenditure (GBP/US$), August’2021
Figure 12-21: Kymriah – Minimum & Maximum Dose for Patients with Less than 50Kg Weight for ALL Management (Million Cells/ Kg), August’2021
Figure 12-22: Kymriah – Minimum & Maximum Dose for Management of Large B-Cell Lymphoma (Million Cells/ Kg), August’2021
Figure 12-23: Alofisel – Price For 4 Vials Supply & Price for Single Vial (US$), August’2021
Figure 13-1: Japan - Temcell Dosage of Cells per Killogram Body Weight (Million)
Figure 13-2: Cost for Single Bag, Single Treatment Cycle & Full Treatment (JPY/US$), May’2020
Figure 13-3: HeartSheet A Kit – Cost of Single Kit (JPY/US$), August’2021
Figure 13-4: HeartSheet B Kit – Cost of Single Kit (JPY/US$), August’2021
Figure 13-5: Stemaric – Minimum & Maximum Dose (Million Cells)
Figure 14-1: Neuronata R – Annual Treatment Cost (KRW/US$), August’2021
Figure 14-2: Invossa – Minimum & Maximum Cost of Suspension (KRW/US$), August’2021
Figure 14-3: Cupistem – Minimum & Maximum Cost of Suspension (US$), August’2021
Figure 15-1: Australia - Ortho-ACI Constituents of Dulbecco’s Modified Eagle Medium (DMEM) nutrient mixture
Figure 15-2: Australia - Ortho-ACI Average Dose (Million Cells) & Cost of Treatment (US$)
Figure 15-3: Apceden – Median Progression-Free Survival in Patients with Solid Tumors (Number of Months)
Figure 15-4: Apceden – Median Progression Free Survival in Patients with Progressive Solid Tumors (Number of Months)
Figure 15-5: Apceden – Availability of Vial & Vials Required in Apceden Therapy
Figure 15-6: Apceden – Intervals Between Multiple Doses of Treatment
Figure 15-7: Apceden – Cost of Single Vaccine, 6 Vaccines & 12 Vaccines (US$/INR), August’2021
Figure 16-1: Significance of Cell Therapy Market Technology
Figure 16-2: Drivers for Growth of Cell Therapy in Japan
Figure 16-3: Criteria Impacting Successful Cell Therapy
Figure 16-4: China Cell Therapy Market Strategy
Figure 16-5: Rest of the World – Cell Therapy Clinical Trial by Region (%), 2019
Figure 19-1: Working of CD4+ & CD25+ Regulatory T-Cell
Figure 19-2: Mechanism of Action of Treg Cell
Figure 19-3: Therapeutic Action of Treg Cell
Figure 19-4: Future Applications of Treg Cells
Figure 20-1: Growth Opportunities for Cell Therapy
Figure 22-1: Bone Therapeutics Clinical Pipeline
Figure 22-2: Celgene Clinical Pipeline
Figure 22-3: Cell Medica Therapeutics Clinical Pipeline
Figure 22-4: Cellerant Therapeutics Clinical Pipeline
Figure 22-5: Fibrocell Science Clinical Pipeline
Figure 22-6: Intrexon Clinical Pipeline
Figure 22-7: Mesoblast Clinical Pipeline
Figure 22-8: Molmed Clinical Pipeline
Figure 22-9: Tigenix Clinical Pipeline
Figure 22-10: Vericel Corporation Clinical Pipeline

List Of Tables

LIST OF TABLES

Table 1-1: Difference between Allogeneic & Autologous Cell Therapy
Table 19-1: Functions of Effector T-Cell & Treg Cell