Sunil Saldanha

CRYOBANKEMPROCELL CLINICAL RESEARCH PVT. LTD., MUMBAI

FETAL TISSUE EXTRACT

Liver

Brain

Spina

l cordKid

ney

Thymus Lun

g

All tis

sue Heat

Pancre

as

Cord

tissue

Placen

ta

Skin +

ribs +

musc

le

Head h

air sk

in

Bladd

er

Body

skin

Cartil

ago

Trache

o-bron

chilla

ris com

pleks

Abdom

en sk

in + m

uscle

Stomac

Bone

Splee

n Eye

Limb m

uscle

Face s

kin

Esopha

gus

Thyroi

d glan

d Gut

Suprar

enal g

land

Aorta

834

490

287

422

150

827

377409

82

431

523 × 10

104 × 10

442

71

231

138

30 36

162

12

261225

439

266

3662

448

171127

Amount (vials - 1.8 ml): 14444 vials ~ 26 l

FETAL ORGANSPECIFIC PROGENITOR CELLS

Liver

Brain

Spina

l cord

Kidne

y

Thymus Lun

g

All tis

sue Heat

Pancre

as

Cord

tissue

Placen

ta

Skin +

ribs +

musc

le

Head h

air sk

in

Body

skin

Abdo

men ski

n + m

uscle

Stomac

Bone

Splee

n Eye

Limb m

uscle

Face s

kin Gut

Suprar

enal g

land

Aorta

337 × 10

423 × 10

262

702

204

466

720

335

187 178

523 104 442 41

77

6

6124

135

4912

64 4717

Amount (vials - 1.8 ml): 11276 vials ~ 20 l

EmProCell Laboratory StructureEmProCell

Biotechnology Lab

Bio-Safety Lab

R&D Lab

Sample Processing

Manufacturing

Cryobank

ELISA

Cell Culture

Pathogen Detection

Karyotyping & Hybridization

Sterilization lab

Bio-Safety Dept- EmProCell Clinical Research Pvt. Ltd. 14/10/2012

Donor Screening

Bio-Safety Dept- EmProCell Clinical Research Pvt. Ltd 14/10/2012

Pregnant women blood ELISA test for:

HBV

HCV

CMV

HTLV

VDRL

Chromogenic End-Point Assay (QCL 1000, Lonza).Kit Sensitivity: 0.01 EU/ml

ELISA Lab

Endotoxin Detection


Pathogen Detection Lab

Standard kits used for :

• DNA Isolation

• RNA Isolation

Nucleic Acid Isolation

Bio-Safety Dept- EmProCell Clinical Research Pvt. Ltd 14/10/2012

HBVHCV CMVEBVHSV1 &2HIV 1 & 2

Treponema pallidum

Mycoplasma hominisUreaplasma sp.Chlamydia all speciesToxoplasma gondii

Pathogen Detected

Pathogen Detection Lab

Bio-Safety Dept- EmProCell Clinical Research Pvt. Ltd.

Pathogen detection Lab


Cell Culture lab


Sterility testing of samples

Outsourced to : Super

Religare LaboratoriesTest performed : Culturing of

Aerobic bacteria Anaerobic

bacteria Yeast/ molds

Method Used : Chemi-luminoscent Assay


Sterility testing of samples at EmProCell


Karyotyping Lab

Traditional karyotypingTo check on any genetic abnormalities in samples

Only Sample with normal karyotype selected


PASSPORT OF CELL SUSPENSIONSample ID: (_ _._ _._ _/_)(_)(_ _ _)(_ _ _ _ _ _)

Type of testing Marker Result Marker Result

Screening Donors(ELISA)

HIV 1 [ ] CMV [ ]

HIV 2 [ ] HTLV [ ]

HBV [ ] VDRL [ ]

HCV [ ]

Cell test-control(PCR)

Pathogen Result Pathogen Result

HBV [ ] HCV [ ]

CMV [ ] EBV [ ]

HSV 1 & 2 [ ] HIV 1 & 2 [ ]

Treponema pallidum [ ] Mycoplasma hominis [ ]

Ureaplasma sp. [ ] Chlamydia (all species) [ ]

Toxoplasma gondii [ ] X-Y chromosome detection [ ]

Microbiology controlSterility testing

Pathogen Result Pathogen Result

Aerobic m/o [ ] Fungus [ ]

Anaerobic m/o [ ]

PASSPORT OF CELL SUSPENSIONGestation period of the

human fetus

(mark as [√])

Weeks Result Weeks Result Weeks Result

6-7 weeks [ ] 13 weeks [ ] 17 weeks [ ]



12 weeks [ ] 16 weeks [ ] 20 weeks [ ]

Cell type

(mark as [√])

Hematopoietic fetal liver stem cells [ ]

Fetal liver hepatoblasts and hepatocytes [ ]

Neural progenitor fetal brain cells [ ]

Quantity & Quality Total Cell Amount per 1 ml

Vible-Cell Amount per 1 ml

Amount of CFU per 1 ml

Amount of mononuclear cells

Karyotyping (FISH)

Transplantation unit: amount of CFU/amount of viable cells

Cryo-protector (mark as

[√])

DMSO [ ]

PVG [ ]

Any other (Name)

PASSPORT OF CELL SUSPENSIONPhenotype of fetal liver hematopoietic stem cells

HLA typing (Type)

CD Marker(mark as [√])

CD Marker Result CD Marker Result CD Marker Result

CD4 [ ] CD56 [ ] CD133 [ ]

CD8 [ ] CD62E [ ] CD135 [ ]

CD12w [ ] CD62P [ ] CD141 [ ]

CD19 [ ] CD69 [ ] CD144 [ ]

CD24 [ ] CD74 [ ] CD158 [ ]

CD27 [ ] CD83 [ ] CD163 [ ]

CD31 [ ] CD90 [ ] CD184 [ ]

CD34 [ ] CD100 [ ] CD202a [ ]

CD42 [ ] CD105 [ ] CD326 [ ]

CD45 [ ] CD117 [ ] CD133 [ ]

Marker Phenotype of fetal liver hepatoblasts and hepatocytes

Result Marker Result Marker Result

AFP [ ] HLA-A [ ] CD74 [ ]

CD326 [ ] HLA-B [ ] CD135 [ ]

Albumin [ ] HLA-DR [ ] CD326 [ ]

C017-1A antigen [ ] CD68 [ ]

PASSPORT OF CELL SUSPENSIONPhenotype of neural fetal brain progenitor cells

Marker Result Marker Result Marker Result

Nestin [ ] HLA-A [ ] CD133 [ ]

β-tubulin III [ ] HLA-B [ ] CD271 [ ]

Vimentin [ ] HLA-DR [ ] CD304 [ ]

GFAP [ ] CD24 [ ] CD326 [ ]

NCAM [ ] CD25 [ ] CD69 [ ]

GalC [ ] CD74 [ ]

Genetic abnormality in cells if any detected by karyotyping:Please enlist __________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

THANK YOU


Sunil Saldanha

Healthcare