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Celution System
Seminar ASPI
25 October 2008
Fat Transfer with Adipose-derived Stem and
Regenerative Cells for Breast Reconstruction
Fat Transfer• Used in reconstruction (to fill defect) and augmentation• Benefit:
– Autologous no rejection, feel more natural– Patient’s preference to reduce the unwanted fat in certain body part as
well as to improve defects in certain body part– No incision scar– Safe in comparison with implant
• Risk: – Fat reabsorption due to necrosis
No more than 3 month tissue survival Produce microcalsification misinterpretation with malignancy in radiology Overcorrection
– Need liposuction• The technique to avoid fat reabsorption:
– Wash the adipose tissue with normal saline– Centrifugation– The addition of nutrients or growth factors– Microinjection of the fat to vascular-rich tissue – Use ADRC
Adipose-derived Stem & Regenerative Cells
• Adult stem cells that have unique properties:– Resides abundantly in adipose tissue the richest
source of stem cells– Differentiate into multiple cell lineages – Extensive self renewal capacity
• Represent tremendous opportunities for treating cardiovascular disease, spine and orthopedic disorders, vascular conditions, reconstructive surgery as well as a variety of other areas of medicine “Regenerative cells”
ADRCs
ADRC vs BM-MSC• Advantages of ADRC
over BM-MSC:– Minimal morbidity upon
harvest– Clinically relevant stem cell
numbers extractable from tissue isolates no need in vitro propagation
– Stem cell frequency is significantly higher in adipose tissue compared with in BM (2% vs 0.002%) 1000 times higher
– Higher proliferation rate than BM-MSC
Strem, Hedrick, Trends in Biotechnology 2005;23(2):64 – 66Fraser, Strem, Nature Clinical Practice Cardiovascular Medicine 2006;3(suppl1):33 – 37
Celution Sytem – Overview• Developed as the 1st bedside device to enable
real-time, adult stem cell processing • This innovative technology automates &
standardized the separation & concentration of a patient’s own (autologous) adult stem & regenerative cells from body fat (adipose) for real-time redelivery to the same patient
• The Celution System makes cells available in about one hour
Celution System
• Celution 800/CRS Device
• Celution 500/CRS Instrument Set
• Celution 805/CRS Kit:– Celution 805/CRS Consumable set– CELASE 835/CRS Reagent – Celution 200/CRS Therapeutic Packs
How it works
Breast Reconstruction
• Breast reconstruction is a physically and emotionally rewarding procedure for a woman who has lost a breast due to cancer or other condition.
• Breast reconstruction is a good option for you if:– You are able to cope well with your diagnosis and treatment – You do not have additional medical conditions or other illnesses
that may impair healing – You have a positive outlook and realistic goals for restoring your
breast and body image
• Breast reconstruction typically involves several procedures performed in multiple stages. It can:– Begin at the same time as mastectomy, or – Be delayed until you heal from mastectomy and recover from
any additional cancer treatments
American Society of Plastic Surgeon
Reconstructive Surgery after Mastectomy
Procedure Advantages General risk Disadvantages
TRAM flapStandard therapy Bleeding, infection,
poor healing of incisions, and
anesthesia risks
-Partial or complete loss of the flap and a loss of sensation at both the
donor and reconstruction site -Produce scar in other place
Latissimus dorsi flap
Standard therapy
-Partial or complete loss of the flap and a loss of sensation at both the
donor and reconstruction site -Produce scar in other place
ImplantNo scar in other place
-Gradual procedure over 4-6 months, tissue expansion
-Capsular contracture firm-Implant Rupture
American Society of Plastic Surgeon
TRAM flap
Latissimus dorsi flap
Tissue expansion in breast implantation procedure
American Society of Plastic Surgeon
Reconstructive Surgery after BCT
• No standard therapy. When the defect is small surgeon will perform tissue arrangement. But when the defect is large enough, no standard therapy was established. Implant can only be done in some special case if the implant size and shape suits the defect which is very rare.
• Good opportunity for breast reconstruction with Celution:– No scar only a point of needle inserted– No capsular contracture– No rupture– No thinning compared with absorbed conventional fat graft– Less risks of bleeding, infection and anesthetic risks since it can
be done with local anesthesia– Flatter tummy at a time
Status: enrollment complete
Reconstruction post-partial mastectomy
Endpoints: safety and efficacy
Design: T2 or smaller, 2 yrs post radiation
therapy 21 patients 6, 12 month follow up
Reconstructive Surgery: RESTORE I
Dr. Sugimachi, Dr. KitamuraDr. Sugimachi, Dr. KitamuraKyushu Central HospitalKyushu Central HospitalFukuoka, JapanFukuoka, Japan
RESTORE I TrialPre-OpPre-Op 12 Months Post-Op12 Months Post-Op
Dr. Sugimachi, Dr. KitamuraDr. Sugimachi, Dr. KitamuraKyushu Central HospitalKyushu Central HospitalFukuoka, JapanFukuoka, Japan
RESTORE I TrialPre-OpPre-Op 12 Months Post-Op12 Months Post-Op
Dr. Sugimachi, Dr. KitamuraDr. Sugimachi, Dr. KitamuraKyushu Central HospitalKyushu Central HospitalFukuoka, JapanFukuoka, Japan
6.1
16.0
14.4
0
2
4
6
8
10
12
14
16
PrePre One monthOne month One yearOne year
P < 0.05 P = NS
P < 0.05
mm
Restore I: Breast Tissue Thickness
Dr. Sugimachi, Dr. KitamuraDr. Sugimachi, Dr. KitamuraKyushu Central HospitalKyushu Central HospitalFukuoka, JapanFukuoka, Japan
* ultrasound* ultrasound
Not satisfiedNot satisfied4 (21.1 %)4 (21.1 %)
Satisfied Satisfied 7 (36.9 %)7 (36.9 %)
Very satisfiedVery satisfied8 (42.1 %)8 (42.1 %)
N= 19
Restore I: Patient Satisfaction Survey
Dr. Sugimachi, Dr. KitamuraDr. Sugimachi, Dr. KitamuraKyushu Central HospitalKyushu Central HospitalFukuoka, JapanFukuoka, Japan
12 Months
Conclusion• Adipose tissue is the richest source of adult stem cell real-time ADRC-
processing with Celution system• ADRC benefits over MSC in:
– More accessible– 1000-times higher frequency no cell processing needed– Higher proliferation rate
• The limitation of conventional fat transfer can be managed by ADRC-enriched fat transfer: no reabsorption good results, no calcification (safe), do not need overcorrection
• The benefits of ADRC-enriched fat transfer over implant:– More natural– No scar only a point of needle inserted– Safer:
• No capsular contracture• No rupture
– Flatter tummy at a time• Indication of ADRC-enriched fat transfer with Celution system:
– Breast reconstruction post BCT & benign tumour (giant FAM, Phylloides)– Breast augmentation
Every woman is created by God beautifully, “big" or "small" depends on how a woman herself sees in her. If there is any dissatisfaction in her body, why not try to change it? Especially she, who had no choice but had to lose hers because of disease. Thank God, He has created every single cell in the human body to be useful, including restoring her beauty and regaining her confidenceThank
you
Correlation between the ADRC Cell Yield to Processing Volume
• Typical yields are approximately 300,000 cells/g of tissue
Adipose tissue volume (g)
ADRC output
100 30,000,000
150 45,000,000
200 60,000,000
250 75,000,000
How long does it take Celution System to process the ADRCs?
How much graft tissue is needed with the ADRCs?
• Cytori’s research has shown that the typical fat graft is made up of 25 – 30% water.
Comparison of 3 sources of MSC BM UCB AT p
Isolation
Number of CFU-F 83±61 0.002±0.004 557±673 p<0.001
Expansion characteristic
Senescence ratio up to passage 2 23.60% 43.60% 5.60% p=0.02 between AT & UCB
Population doubling numbers lowest highest in the middle
Maximal passage P7 P10 P8
Multilineage differentiation potential
Osteogenic differentiation capacity 78.8% 100% 71.40% Non significant
Adopogenic differentiation capacity 100% 0 94% p<0.01
Chondrogenic differentiation capacity All samples show cartilage-type phenotype with chondrocyte-like lacunae
Differentiation capacities into all three lineages 71.40% 0 71.40%
Multilineage differentiation capacity of BM-CFU-F & AT-CFU-F
towards all 3 lineages 28.60% 89.30% p<0.001
towards 2 lineages 64.20% 7.10% p<0.001
Kern, Stem Cells 2006;24:1294 – 1301
Expression of Surface Proteins of MSCs derived from BM, UCB & AT