Bone and Cartilage regeneration with cells and tissue engineering products - Dr. Enric Cáceres - B-Debate 17/02/2015 http://www.bdebate.org/en/forum/advanced-therapies-and-regenerative-medicine-promise-21st-century
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Bone and Cartilage regeneration with cells and tissue engineering products - Dr. Enric Cáceres - B-Debate 17/02/2015
1. Bone and Cartilage regeneration with cells
and tissue engineering products
Enric Càceres
Chair Orthopaedics
Universitat Autònoma de Barcelona
2. The role of mesenchymal stem cells
• Management of large bone defects and cartilage
loss continues to be a challenge
• Urist 1970 discovers Bone Morphogenetic Protein
• Autologous or allogeneic MSCs can be expanded
and then may be loaded in the variety of scaffolds
3. The role of mesenchymal stem cells
MSCs Origin
•Bone marrow
•Adipose tissue (including fat pad from knee)
•Periostium
•Synovium
•Artery walls
6. XCEL-MT-10-02
• Lumbar fusion in degenerative surgery:
Autologous iliac graft Gold standard
– Local complications
– Limited amount of material
No union 5-35% (depending condition)
• Alternatives:
• BMP
• Mesenchyme Stem Cells
7. XCEL-MT-10-02
PUBMED:
Mesenchymal stem cells 26129
Mesenchymal stem cells and bone regeneration 2911
Mesenchymal stem cells and spinal fusion 86
Mesenchymal stem cells and spinal fusion, clinical trial 3
8. XCEL-MT-10-02
Biomaterials. 2008 Oct;29(29):3973-82. doi: 10.1016/j.biomaterials.2008.06.026.
Epub 2008 Jul 18.
The clinical use of enriched bone marrow stem cells combined with porous
beta-tricalcium phosphate in posterior spinal fusion.
Gan Y, Dai K, Zhang P, Tang T, Zhu Z, Lu J.
Department of Orthopaedics, Shanghai Ninth People's Hospital, Shanghai Jiaotong
University School of Medicine, Shanghai, People's Republic of China.
41 patients / 95% posterolateral fusion
9. XCEL-MT-10-02
Zhonghua Wai Ke Za Zhi. 2008 Apr 1;46(7):493-6.
Clinical study of lumbar fusion by hybrid construct of stem cells
technique and biodegradable material.
[Article in Chinese]
Zhang P, Gan YK, Tang J, Hao YQ, Wang Y, Sun YH, Zhu ZA, Dai KR.
Department of Orthopaedics, Shanghai Ninth People's Hospital, School of Medicine of
Shanghai Jiaotong University, Shanghai 200011, China.
Bone marrow mesenchyme stem cells hybridized with
beta-tri calcium phosphate 93% fusion
Autologous iliac crest bone graft 96% fusion
10.
11. 11
Title: "Ex Vivo" Expanded Autologous Bone Marrow
Mesenchymal Stem Cells Fixed in Allogenic
Human Bone Tissue for Spinal Fusion in Spine
Degenerative Disease (XCEL-MT-OSTEO-ALPHA)”
Target: Degenerative Spondylolisthesis L4-L5 degrees I-II
of Meyerding
Product: XCEL-MT-OSTEO-ALPHA
Promotion: BST (Banc de Sang i Teixits)
Source: Agencia Nacional del medicamento
XCEL-MT-10-02
12. XCEL-MT-10-02
Design: Phase I/II, prospective, open (blind assessment),
randomized, parallel, only one dose and multicentric
Centres / IP: Vall d’Hebron, Hosp Germans Trias i Pujol, Hosp del
Mar, Hosp St Pau, ICATME-Dexeus
Objectives: 1st: To evaluate viability and safety of the product
Second: Assess efficacy through image (CT and XR
evaluation of fusion status at 6 and 12m) and clinical
assessment( VAS, Oswestry, SF-36)
17. Purpose and hypothesis
Purpose
Randomized study, compares the spinal fusion obtained after
instrumentation and the use of a biologic product (patients MSCs bone
marrow fixed in human bone tissue from a donor), with the current
procedure that consist in instrumented spinal fusion and the use of
each patient’s bone obtained from his/her iliac crest
Working hypothesis
Proposes that the tissue engineering is valid and useful technique to
achieve bone regeneration avoiding iliac crest patient harvesting
18. 18
Sample: 62 Patients, age18-85a, bout sex.
Group A: Surgical fusion using autologous mesenchymal cells
expanded “ex vivo” fixed in allogenic osseous matrix (XCEL-MT-
OSTEO-ALPHA)”
Group B: Surgical fusion using autologous iliac graft
XCEL-MT-10-02
25. Initial harvest bone marrow
Spread Cell Stack
Microscopically assessment of the sample
celularity and brooding culture
Culture andCulture and
enlargementenlargement
26. Volume Reduction (Spin cycle place the MSCc at the
bottom of the pack)
CellStacks
Strict
conditions
Cèl-lules mesenquimals, previes a la colonització
39. Non expanded MSCs
• Avoid cost and time
• Depend on the number and concentration
• <1000 cell per cm3
or< 30.000 cells in total
• Small volumes range 2 / 4 ml in aspiration
• Centrifuging the aspirate before injection
• Lack of strict analysis in many current
practice
40.
41. Future MCSs in Orthopedics
Looks promising as advances in
• Tissue engineering
• Biomaterial
• Cell biology
Converge
• To play a major role in the repair and
regeneration of musculoskeletal disease and
injuries