Mesenchymal Stromal Cells(Banc de Sang i Teixits)(Mesenchymal Stromal Cells(Banc de Sang i Teixits))

概要

基本信息

药物类型

间充质干细胞疗法

别名

XCEL-M-ALPHA、XCEL-MT-OSTEO-ALPHA

靶点-

作用方式-

作用机制

干细胞替代物

治疗领域

皮肤和肌肉骨骼疾病其他疾病

在研适应症-

非在研适应症

萎缩性不愈合骨折半月板损伤假关节

原研机构

Banc de Sang I Teixits

在研机构-

非在研机构

Banc de Sang I Teixits

权益机构-

最高研发阶段无进展临床1/2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

3

项与 Mesenchymal Stromal Cells(Banc de Sang i Teixits) 相关的临床试验

NCT02230514

/ Completed临床1/2期IIT

A Phase IIa, Single Center, Prospective, Randomized, Parallel, Two-arms, Single-dose, Open-label With Blinded Assessor Pilot Clinical Trial to Assess ex Vivo Expanded Adult Autologous Mesenchymal Stromal Cells Fixed in Allogeneic Bone Tissue (XCEL-MT-OSTEO-ALPHA) in Non Hypertrophic Pseudoarthrosis of Long Bones

The present study evaluates the effect of XCEL-MT-OSTEO-ALPHA in non-union fractures (pseudoarthrosis) of long bones in comparison to the standard treatment of autologous iliac crest.
XCEL-MT-OSTEO-ALPHA is a tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stromal cells fixed in allogenic bone tissue, produced by Xcelia (Blood and Tissue Bank of Catalonia).
The working hypothesis proposes that the tissue engineering is a valid and useful technique to achieve bone regeneration up to consolidation of non-union fractures.

开始日期2014-11-20

申办/合作机构

Banc de Sang I Teixits

NCT02033525

/ Completed临床1/2期IIT

A Phase I-IIa Safety and Efficacy Pilot Clinical Trial of Intraarticular Administration of Autologous Mesenchymal Cells for Meniscus Injury

The present proposal has the objective to assess whether the addition of autologous ex vivo expanded mesenchymal stromal cells (XCEL-M-ALPHA) to the conventional meniscal injury rehabilitation program is contributing in creating the proper healing environment for the meniscus repair. For this purpose, 20 patients will be randomized (10 per group) to one of the two treatment arms (rehabilitation + xcel-m-alpha or rehabilitation alone) . The conduction of this clinical trial will, in addition of having the aim of improving the patient's quality of life, contribute to consolidate an emerging new type of therapy which is still under development.

开始日期2014-01-31

申办/合作机构

Banc de Sang I Teixits

EUCTR2010-022909-18-ES

/ Recruiting临床2期IIT

Ensayo clínico Fase II para evaluar la eficacia y seguridad de la aplicación de Células Progenitoras de Médula Ósea Autóloga expandidas en el tratamiento quirúrgico de pseudoartrosis no hipertróficas de fémur, tibia y húmero, tras un primer fracaso terapéutico.

开始日期2011-03-21

申办/合作机构-

100 项与 Mesenchymal Stromal Cells(Banc de Sang i Teixits) 相关的临床结果

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100 项与 Mesenchymal Stromal Cells(Banc de Sang i Teixits) 相关的转化医学

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100 项与 Mesenchymal Stromal Cells(Banc de Sang i Teixits) 相关的专利（医药）

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1

项与 Mesenchymal Stromal Cells(Banc de Sang i Teixits) 相关的文献（医药）

2016-08-01·The Knee4区 · 医学

Final results of a phase I–II trial using ex vivo expanded autologous Mesenchymal Stromal Cells for the treatment of osteoarthritis of the knee confirming safety and suggesting cartilage regeneration

4区 · 医学

Article

作者: Soler, Robert ; Orozco, Lluis ; Codinach, Margarita ; Vives, Joaquim ; López, Ramon ; Coll, Ruth ; Garcia-Lopez, Joan ; Munar, Ana ; Huguet, Marina

BACKGROUND:

Cellular therapies have shown encouraging results in the treatment of chronic osteoarthritis (OA). Herein, we present the final results of a phase I-II clinical trial assessing the feasibility, safety and efficacy of ex vivo expanded autologous bone marrow Mesenchymal Stromal Cells (MSC, XCEL-M-ALPHA), infused intra-articularly, in patients with knee OA.

METHODS:

Fifteen patients (median age=52years) with grade II(9) or III(6) gonarthrosis (Kellgren & Lawrence classification) and chronic pain were treated with an intra-articular infusion of 40.9×10(6)±0.4×10(6) MSCin a phase I-II prospective, open-label, single-dose, single-arm clinical trial. Endpoints were safety and tolerability. Efficacy was measured by the Visual Analogue Scale for pain, algofunctional Health Assessment Questionnaire, Quality of Life (QoL) SF-36 questionnaire, Lequesne functional index and WOMAC score. Cartilage integrity was assessed by Magnetic Resonance Imaging and quantitative T2-mapping at 0, 6 and 12months.

RESULTS:

The cell-based product was well tolerated with few reported Adverse Events (mild arthralgia and low back pain). There was a relevant decrease in the intensity of pain since day 8 after the infusion, that was maintained after 12months. The SF-36 QoL test showed improvement of parameters including bodily pain, role physical and physical functioning at month 12. The health assessment questionnaire revealed a significant decrease of incapacity. Moreover, T2 mapping showed signs of cartilage regeneration in all patients at 12months post-treatment.

CONCLUSIONS:

Single intra-articular infusion of XCEL-M-ALPHA is a safe and well-tolerated cell-based product, associated with a long-lasting amelioration of pain, improvement of QoL (up to four years), and signs of cartilage repair.

100 项与 Mesenchymal Stromal Cells(Banc de Sang i Teixits) 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
萎缩性不愈合骨折	临床2期	西班牙	Banc de Sang I Teixits	2014-11-20
假关节	临床2期	西班牙	Banc de Sang I Teixits	2014-11-20
半月板损伤	临床2期	西班牙	Banc de Sang I Teixits	2014-01-31

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


Pubmed \| Knee 人工标引	临床1/2期	膝关节炎	15	autologous Mesenchymal Stromal Cells	鏇鹽遞餘簾醖衊構繭鹽(簾繭餘顧齋鹽糧襯醖衊) = was few reported(mild arthralgia and low back pain) 齋網醖製鏇選製範夢蓋 (鏇積網鹹窪衊蓋繭簾鬱 ) 更多	积极	2016-01-11