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GENReports: Market & Tech Analysis
> Enal Razvi, Ph.D.
Managing Director
Select Biosciences, Inc.
[email protected] GENengnews.com GENReports: Market & Tech Analysis, Produced by Enal Razvi, Ph.D. © 2014 Scope of this Report: Clinical Trials Using Fat-‐
derived Stem Cells •  There is much interest of late in the deployment of adipose Assue and adipose-‐derived stem cells for regeneraAve medicine •  The use of adipose Assue in cosmeAc and reconstrucAve surgery is well documented and now there is a collision taking place between clinicians who are focusing on adipose Assue and clinician-‐scienAsts who are seeking to understand the acAve moieAes within the adipose Assue—namely the adipose-‐derived stem cells as well as other components of this milieu which mediate regeneraAon •  In this GEN report we explore this expanding space Clinical Trials Assessing the UFlity of Adipose-‐derived Stem Cells for RegeneraFve Medicine in Various Disease Classes is the Focus of this Report GENengnews.com GENReports: Market & Tech Analysis, Produced by Enal Razvi, Ph.D. © 2014 Clinical Trials IniFated in 2011 Trial ID
Country Phase
Condition
Cell type/
Manipulation
Donor Acad/
type Industry
Company # pts to
Sponsor
enroll
Ageless Regenerative
Institute
10
Ageless Regenerative
Institute
10
Ageless Regenerative
Institute
10
NCT01502514 Mexico
1
heart failure
SVF
auto
industry
NCT01502488 Mexico
1/2
SVF
auto
industry
NCT01502501 Mexico
1/2
autism
non-ischemic
heart failure
auto
industry
NCT01399749
1/2
SVF
adipose SC expanded/
chondrocytes
auto
academia
30
adipose SC expanded
auto
academia
60
adipose SC expanded
auto
industry
Cellerix
56
SVF on synthetic graft
(TE)
auto
industry
Tissue Genesis
60
auto
industry
RNL Bio
8
auto
industry
Regeneus Pty
40
Anterogen
6
Spain
NCT01449032 Denmark
2
NCT01378390
Spain
3
NCT01305863
US
1/2
osteoarthritis
heart failure
ischemic
Chron's disease
Peripheral
Vascular
Disease
NCT01274975 S. Korea
1
spinal cord injury adipose SC expanded
ACTRN126110
unknow
01046998
n
Australia
osteoarthritis
SVF
KCT0000188 S. Korea
1
Crohn's fistula
ACTRN126110
unknow
00274976
n
Australia
osteoarthritis
GENengnews.com adipose SC expanded
SVF
allo
industry
unknow
n
academia
60
GENReports: Market & Tech Analysis, Produced by Enal Razvi, Ph.D. © 2014 Clinical Trials IniFated in 2012 Trial ID
Country Phase
Condition
Cell type/ Manipulation
Donor
type
Acad/
Industry
Company - Sponsor
# pts to
enroll
Cytori
20
NCT01556022
US
1/2
cardiology (chornic
myocardial ischemia)
SVF
auto
industry
NCT01559051
Mexico
1/2
COPD (lung disease)
SVF
auto
academia
NCT01586715
Spain
2
perianal fistulae
SVF
auto
academia
spinal cord injury
adipose SC expanded
auto
industry
Bukwang Pharmaceutical
osteoarthritis
SVF
auto
industry
Regeneus Ltd
osteoarthritis
adipose SC expanded
auto
academia
NCT01624779
S. Korea
1
ACTRN1261200067
2853
Australia unknown
NCT01585857
France
EUCTR2011-006064 Spain
-43-ES
(EU)
1
3
perianal fistulae
adipose SC expanded
allo
industry
NCT01548092
Spain
1/2
recto-vaginal fistula
SVF
auto
academia
NCT01584713
Spain
1/2
Enterocutaneous Fistula
SVF
auto
academia
EUCTR2010-01977
4-33-ES
Spain
1/2
CLI diabetic
BM MNC/ CD133+, adipose SC
expanded
auto
academia
NCT01643681
S. Korea
1/2
adipose SC expanded
auto
30
10
18
Cellerix AS /TiGenix
208
industry
RNL Bio
8
NCT01643655
S. Korea
1/2
orthopedics - vertebral disc
degeneration
orthopedics - femoral head
necrosis
adipose SC expanded
auto
industry
RNL Bio
15
NCT01663376
S. Korea
1/2
CLI
adipose SC expanded
auto
industry
RNL Bio
20
NCT01674439
IRCT201202169044
N1
Brazil
2
plastic surgery
SVF
auto
academia
22
Iran
unknown
burns
adipose SC expanded
auto
academia
30
NCT01709279
JPRNUMIN000009066
Japan
1
heart failure
adipose SC expanded
auto
academia
6
Japan
1?
ischemic heart failure
SVF
auto
academia
6
NCT01745744
Spain
IRCT201207071020
1N1
Iran
EUCTR2011-001393
-26-ES
Spain
GENengnews.com JPRNUMIN000007698
Japan
1/2
CLI
adipose SC expanded
auto
academia
33
unknown
scars - cosmetics
adipose SC expanded
auto
academia
60
2
ischemic stroke
adipose SC expanded
unknown
academia
20
unknown
periodontitis
SVF
auto
academia
12
GENReports: Market & Tech Analysis, Produced by Enal Razvi, Ph.D. © 2014 Clinical Trials IniFated in 2013 Trial ID
NCT01769872
NCT01771913
NCT01801878
NCT01799876
NCT01803347
NCT01809769
NCT01824069
NCT01828723
NCT01840540
NCT01850342
NCT01853501
NCT01856140
NCT01885819
NCT01885832
NCT01889888
IRCT2012091781
77N5
NCT01902082
EudraCT
2012-000292-16
NCT01915927
NCT01974128
Country Phase
S. Korea
1/2
Brazil
Condition
spinal cord injury
plastic breast
reconstitution
2
unknow
n
S. Korea
skin cosmetic defects
unknow
n
US
orthopedics/ trauma
Spain
3
perianal fistula (IBD)
China
1/2
knee osteoarthritis
Spain
1/2
CLI
US
1
skin cosmetic defects
atherosclerotic kidney
occlusive disease
US
1
Russia
1/2
urinary incontinence
premature ovarian
failure
China
4
unknow
n
S. Korea
orthopedics/ trauma
Panama
1/2
rheumatoid arthritis
Panama
1/2
osteoarthritis
Russia
1/2
urethral strictures
Iran
China
Spain
US
Mexico
UMIN000010143
Japan
GENengnews.com NCT02024269
US
ACTRN12613001
332718
Australia
Cell type/ Manipulation
adipose SC expanded
Donor
type
auto
Acad/
Industry
industry
SVF
auto
academia
SVF
auto
academia
1
myocardial infarction
CLI
eye diseases
wounds (venous leg
ulcers)
# pts to
enroll
15
24
10
InGeneron, Inc. / Fondren
Orthopedic Group
SVF
adipose SC expanded
SVF
adipose SC expanded
SVF
auto
auto
auto
auto
auto
industry
academia
industry
academia
industry
adipose SC expanded
SVF
auto
auto
academia
academia
15
12
adipose SC expanded
auto
academia
4
adipose SC expanded
SVF
SVF
SVF
adipose SC expanded +
amniotic membrane (TE)
adipose SC expanded
allo
auto
auto
auto
academia
industry
industry
academia
auto
allo
academia
academia
20
20
auto
academia
8
auto
academia
1/2
burns
1
ARDS
unknow
n
bronchopleural fistula
adipose SC expanded
perianal fistula (Crohn's adipose SC expanded + matrix
disease)
(TE)
1
1/2
unknow
n
1
Company - Sponsor
RNL Bio
SVF
auto
industry
Cellular Biomedicine Group
Antria
Translational Biosciences
Translational Biosciences
48
80
120
10
6
12
20
20
12
20
Ageless Regenerative
Institute
10
SVF Market & Tech autoAnalysis, academia
GENReports: Produced by Enal Razvi, Ph.D. © 2014 40
SVF
auto
industry
SVF
auto
academia
Bioheart Inc.
100
60
Summary of IndicaFons Addressed in the Trials Cardiovascular
Neurology/
behavioral
Muskuloskeletal
Skin diseases/
defects
Digestive tract
(incl. fistulae)
GENengnews.com 2011
4
2012
6
2013
4
2
3
2
5
1
7
0
3
5
2
4
2
GENReports: Market & Tech Analysis, Produced by Enal Razvi, Ph.D. © 2014 Breakout of the Trials UFlizing Adipose-‐Derived SCs Total number of Trials 30 25 20 15 21 23 11 10 5 0 2011 GENengnews.com 2012 2013 GENReports: Market & Tech Analysis, Produced by Enal Razvi, Ph.D. © 2014 Breakout of the Trials vis-‐à-‐vis Type of SCs Deployed SVF Adipose SC expanded 100% 80% 10 6 12 60% 40% 13 20% 5 9 0% GENengnews.com 2011 2012 2013 GENReports: Market & Tech Analysis, Produced by Enal Razvi, Ph.D. © 2014 SVF: Stromal vascular fracAon The Stakeholders in Adipose Tissue and Stem Cells for RegeneraFve Medicine Come Together at the Clinical TranslaFon of Stem Cells 2014 Select Biosciences Conference Brings Together all the Stakeholders in this Broad Space Composed of Clinical TranslaFon of Stem Cells v 
v 
v 
v 
Focus on Adipose Tissue as a Means for MediaAng RegeneraAve Medicine Blend of Clinicians, Surgeons, Clinician-‐ScienAsts, and Researchers Current Progress and Challenges in the Clinical Deployment of Stem Cells Stem Cells for Dermatological, Orthopedic, and Dental ApplicaAons à Illustrated by PresentaAons from Clinicians from Around the World v  Clinical PracAcum à Presents Hands-‐On and in Real-‐Time the IsolaAon and Processing of Adipose Tissue to Harvest Stem Cells v  John Sterling, Editor-‐in-‐Chief of GEN Hosts a Panel DMiscussion Focusing n the Bbig icture RegeneraAve GENengnews.com GENReports: arket & Tech Analysis, o
Produced y EPnal Razvi, oPf h.D. © 2014 Medicine The Stakeholders in Adipose Tissue and Stem Cells for RegeneraFve Medicine Come Together at the Clinical TranslaFon of Stem Cells 2014 Topics Addressed v  Adipose-‐derived Stem Cells v  Clinical UAlity Illustrated with Case Studies v  Clinical PerspecAves v  CosmeAc Surgery and Associated ApplicaAons v  Clinical TranslaAonal ApplicaAons with Pluripotent Stem Cells v  Disease Classes Addressed and Current Status of Ongoing Clinical Trials with Adult Stem Cells v  Regulatory Landscape and Ethical ConsideraAons v  TranslaAonal Research AcAviAes with Adult Stem Cells v  Dental ApplicaAons v  Orthopaedic ApplicaAons v  Dermatological ApplicaAons v  Veterinary ApplicaAons of Stem Cells GENengnews.com GENReports: Market & Tech Analysis, Produced by Enal Razvi, Ph.D. © 2014 For More InformaFon: hVp://selectbiosciences.com/conferences/index.aspx?conf=CTSC2014

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