VesCell Stem Cell Results for Treatment of Severe Heart Disease

8/14/2019 VesCell Stem Cell Results for Treatment of Severe Heart Disease

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CELL THERAPY FOR THECELL THERAPY FOR THETREATEMENT OF SEVERETREATEMENT OF SEVERE

HEART DISEASEHEART DISEASEUsingUsing

Intracoronary & IntramyocardialIntracoronary & IntramyocardialInjected ACPsInjected ACPs


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Clinical Trial in Angina pectorisClinical Trial in Angina pectorisPatientsPatients

To determine the safety andTo determine the safety andefficacy of intracoronaryefficacy of intracoronaryinjection of autologousinjection of autologousACPs in relieving symptomsACPs in relieving symptomsof angina pectoris inof angina pectoris inpatients on maximal medicalpatients on maximal medical

therapytherapy
http://opt/scribd/conversion/tmp/scratch3/C:/Documents%20and%20Settings/yael_p/My%20Documents/Presentations/Yael%20Stem%20cell/StemCellAnimation_FINALVERSION.EXE


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First ACPs injection on August 2004First ACPs injection on August 2004


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Clinical Trial Safety ResultsClinical Trial Safety Results

Deaths Serious Adverse Events Adverse Events

1 3 in 3 patients 10 in 7 patients

MI of an

unrelatedartery[Stent

blockage]

Transient ventricular

fibrillation during celladministration procedure (1)

Transient ventricularfibrillation during follow upprocedure of catheterizationat 6 months after cell

administration (2)

Elevated Erythrocyte Sedimentation Rate

(2) Chest pain during cell administration (1) Hypoglycemia (1) Upper respiratory tract infection (1) Oral paresthesia (1) Urticaria (2) Hematoma at puncture site Leg Pain (1)

24 Patients - NO GVHD

No serious adverse events were attributed to theinjected cells

1 Death (unrelated)

Very few adverse effects

Rare events of transient arrhythmia (related to

catheterization)

No evidence of tumoregenesis


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Angina PectorisPatients

Objectiveparameters

Perfusion of heartmuscle

Work load capacity

Most of the effectachieved by 3months aftertreatment

Clinical TrialClinical Trial3 and 6 months follow-up results3 and 6 months follow-up results

B e f

o r e

A f t e r


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Angina Pectoris PatientsSubjective parameters

CCS (Angina score)Exercise capacity 6 minute walking

test

Clinical TrialClinical Trial3 and 6 months follow-up results3 and 6 months follow-up results

Six Minutes Walking Test

338 410 423300

320

340

360

380

400

420

440

460

Baseline 3 Months 6 Months

Distance(meters)

P=0.0018 *

P


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> 300 Out-of-Study PatientsCategorized by Procedures

134

174

9

317

0

50

100

150

200

250

300

350

N u m

b e r

Intramyocardial Intracoronary PAD Total Procedure


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Medical History

50%(134)

16%(43)

11%(28)

22%(60) 38.5%

(103)

32.5%(87)

40%

(107)

11%(28)

36%(95)

10%(27)

22%(59)

16%(43)

10%(27)

4%(11)

33%(89)

24%(63)

0

20

40

60

80

100

120

140

160

180

200

N u m b e r

I s c h e

m i c C

a r d i o m

y o p a

t h y

N o n

- I s c h

e m i c

C a r d i

o m y o

p a t h y

V a l v e

d i s o

r d e r

S / P P T

C A

S / P C A B

G

A r r h y

t h m i a

A n g i n

a

S / P P a

c e m a

k e r

Diseases

Intracoronary Intramyocardial66%

57%

14%

38%

46%

51%

71%

33%

Patients also had


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Patient Gender

Male90%

Female10%


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Patient Age Distribution

50-5924%

40-497%

30-394%

60-6933%

70-7925%

80-896%

90-940.4% 20-291.1%


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Country of OriginU.A.E., 1%Singapore,

1%

Canada, 1%

Myanmar, 2%India, 2%

Others7%

U.S.A .79%

Thailand5%

Australia, 2%

Azerbaijan, China, Germany, Indonesia, Israel, New Zealand, Abudhabi, England, Philippine, Italy,Mexico, Netherland, Parkistan, and Span

Others :


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Results by

Treatment and Diagnosis


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NYHA, CCS scoreIntracoronary delivery

Statistical Method : Wilcoxon Signed Ranks Test

* Significant improvement (p


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Ejection Fraction

35

46

0

5

10

15

20

25

30

35

40

45

50

Baseline 2-4 Months

E F

P=0.046

(E) Stress EF(%) by Tc 99mSesta MIBI / SPECT

Statistical Method : Paired T-test

Intracoronary delivery

* Patients number from whom tests results were sent by the physicians, N=12


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2.0

2.6

0

0.5

1

1.5

2

2.5

3

Baseline 2 -6 Mon ths

N Y H A S c a

l e

(A) NYHA ClassificationN = 76

P=0.000*

3 1 .

3 0 .

0

5

1 01 5

2 0

2 5

3 0

3 5

4 0

B a s e lin e 2 - 6 M on th s

E F ( % )

( B) Re s t EF(%) b y Ech o c a r d i o gN = 54

P =0.35 1

35

33.4

0

5

10

15

20

25

30

35

40

Bas elin e 2- 6 Month s

E F ( % )

(C) Rest EF(% ) by C-MRI/SPE CT/ Sesta MIBI, N = 1

P=0.731

Ischemic CHF




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1,105

2,601

0

500

1000

1500

2000

2500

3000

Baseline 2-6 Months

B N P ( p g

/ m l

(D) BNP (pg/ml)N = 10

P=0.116

1,247

361

0

200

400

600

800

1000

1200

1400

Baseline 2-6 Months

M e

t e r ( s

)

(E) 6 Minute Walking TestN = 10

P=0.163

Statistical Method : Paired T-test

Ischemic CHF


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1.9

2.6

0

0.5

1

1.5

2

2.5

3

Bas eline 2-6 Months

N Y H A

S c a l e

P=0.000*

NYHA C lassification N = 76

(C )

3,870

1,153

0

500

1000

1500

2000

2500

3000

3500

4000

4500

Bas eline 2- 6 Months

B N P ( p g

/ m l )

P=0.015

BNP (pg/ml)N = 13

(D)

36 1

97 2

0

200

400

600

800

1000

1200

Bas eline 2- 6 Months

M e t e r

( s )

P=0.246

6 M inute Walking T est N = 12

(E)

Non-ischemic Cardiomyopathy




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Clinical Experience

36.15

60.91

32.1

57.58 57.96

69.42

36.25

52.04

35.31

52.45

58.55

72.14

64.24

77.75

69.41

74.58

0

20

40

60

80

100

0 - 1

0 0 S c o r e

PF RP BP GH VT SF RE MH

Pre-SC Tx 3-6 Months Post SC Tx (N=96)Comparison between Pre-SC Tx and 3-6 Months Post-SCTx

SF-36 V2 TM Health Survey

Definition

PF Physical Function

RP Role PhysicalBP Bodily Pain

GH General Health

VT Vitality

SF Social Function

RE Role Emotional

MH Mental Health

SF-36v2TM Health Survey@1996,2000 by Quality Metric Incorporated and Medical Outcomes Trust-All Rights ReservedSF-36 is a registered trademark of Medical Outcomes Trust

(SF-36 v2 Standard ,US Version 2.0)


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42.72

54.89

41.58

55.57

64.2267.04

43.42

54.07

39.17

50.41

60.33

71.2

61.78

77.54

67.78

75.22

0

20

40

60

80

100

0 - 1

0 0 S c o r e

PF RP BP GH VT SF RE MH

Pre-SC Tx 1 Year Post SC Tx (N=46)

Definition

PF Physical Function

RP Role Physical

BP Bodily Pain

GH General Health

VT Vitality

SF Social Function

RE Role Emotional

MH Mental Health

Comparison between Pre-SC Tx and 1 Year Post-SC Tx

SF-36 V2TM Health Survey

Clinical Experience

SF-36v2TM Health Survey@1996,2000 by Quality Metric Incorporated and Medical Outcomes Trust-All Rights ReservedSF-36 is a registered trademark of Medical Outcomes Trust

(SF-36 v2 Standard ,US Version 2.0)


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Death9%

Alive91%

DeathAverage follow up period = 5.5+1 month

Range follow up period = 1-24 month

Intracoronary (10):

- 3 Cardiac arrest

- 3 Heart Failure

- 1 Septic Shock S/P pneumonia - 1 Ac. Renal shut down with MOF

- 1 Aneurysm with metastasis pancreas cancer

- 1 Suicide

Intramyocardial (19):

- 7 Cardiac arrest

- 3 Heart Failure

- 6 Unknown cause (Post SC Tx >6months)

- 2 Ac. Renal failure

- 1 End stage CA

> 300 Out-of-study PatientsSafety

No deaths or SAEs can be directly attributed to the stem cells injection

Completed absence of tumoregenesis evidence.

No GVHD


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Safety> 300 Out-of-study Patients

Serious Adverse Events (SAEs)

Intracoronary Intramyocardial Recurrent CHF (12) Temporary recurrent PVCs (6)

Priaprism (1) Ventricular Fibrillation (twice in 1 pt)

Pneumonia/ Pleural effusion (5) Ventricular Tachycardia (3)

Repeated MI (2) Atrial Fibrillation (5)

Defibrillator implantation (2) Unspecified Arrhythmia (1)

Ac. Renal failure (1) Cardiac arrest (twice in 1 pt)

GI Bleeding (1) Recurrent CHF (10)

Hemodialysis (3) Peumonia/ Pleural effusion (6)

Heart transplantation (2) Defibrillator misfiring (2)

Embolic stroke (1) Ac.Renal failure (2)

Bronchitis (1) Episode of TIA (S/P gall bladder) (1)

Influenza (1) Gout attack (1)

Hyperglycemia (1) Hemodialysis (5)

Hyponatremia (1) Influenza (1)

Prolong hospitalization (2)

Pericardial effusion (1)

34 (10.7%) 48 (15.1%)


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ConclusionIntracoronary & Intramyocardial injection

Intracoronary & Intramyocardial ACPs implantation is safe and

effective.

Significant improvement of the CCS, NYHA and the quality of

life in both intracoronary and intramyocardial approach.

The CCS, NYHA, BNP, 6MW and the LVEF% function had

improved in Ischemic CHF, CHF with Angina, and Non-

ischemic cardiomyopathy


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Peripheral Arterial DiseasePeripheral Arterial DiseaseFirst patient treated on April 11,2006First patient treated on April 11,2006

Clinical ExperienceClinical Experience


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Diabetic PAD Treatment

Clinical ExperienceClinical Experience

Two days laterInjection


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Pre-OperationPre-Operation Day 17Day 17 Day 33Day 33 Day 90Day 90

Pre-Pre-OperationOperation

55MonthsMonths

Clinical Trial - PADClinical Trial - PAD

Date post:	30-May-2018
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