Multicenter, Randomized, Open-Label, Standard Treatment-Controlled Parallel Group Phase 2 Study to Evaluate Efficacy and Safety of Intra-Articular Injections of Autologous Peripheral Blood Stem Cells and Hyaluronic Acid Adjuvant Therapy Following Subchondral Drilling Surgery for the Treatment of Articular Cartilage Injury in the Knee With an Optional Open-Label Extension for the Standard Treatment-Controlled Group

This is a 24-month, multicenter, randomized, open-label, standard treatment-controlled, parallel-group, Phase 2 study for adults with large or complicated knee articular cartilage lesions and are candidates for knee joint cartilage repair surgery. The safety and efficacy of intra-articular injections of peripheral blood stem cells (PBSCs) together with hyaluronic acid (HA) after subchondral drilling surgery will be evaluated to determine whether PBSC therapy can improve functional outcome and reduce pain of the knee joint better than a standard treatment (HA injections and physiotherapy regimen).

开始日期2015-12-01

申办/合作机构

KLSMC Stem Cells, Inc.

100 项与 Autologous peripheral blood stem cells(KLSMC Stem Cells) 相关的临床结果

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100 项与 Autologous peripheral blood stem cells(KLSMC Stem Cells) 相关的转化医学

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100 项与 Autologous peripheral blood stem cells(KLSMC Stem Cells) 相关的专利（医药）

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项与 Autologous peripheral blood stem cells(KLSMC Stem Cells) 相关的文献（医药）

2021-12-01·CARTILAGE3区 · 医学

Novel Use of Intraarticular Granulocyte Colony Stimulating Factor (hG-CSF) Combined with Activated Autologous Peripheral Blood Stem Cells Mobilized with Systemic hG-CSF: Safe and Efficient in Early Osteoarthritis

3区 · 医学

Article

作者: Papadopoulos, Konstantinos I. ; Turajane, Thana ; Sutheesophon, Warachaya ; Paisan, Mantana

Osteoarthritis (OA) tends to occur in older individuals frequently burdened with comorbidities and diverse pharmacological interactions. As articular cartilage has low regenerative power, potent local tissue engineering approaches are needed to support chondrogenic differentiation. Acellular preparation methods as well as approaches to coax endogenous reparative cells into the joint space appear to have limited success. Supported by our in-vitro and clinical studies, we propose that our novel intra-articular administration of human granulocyte colony stimulating factor (IA-hG-CSF) combined with autologous activated peripheral blood stem cells (AAPBSC) is safe and offers treatment advantages not seen with other cellular interventions in early osteoarthritis.

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
膝关节病变	临床2期	美国	KLSMC Stem Cells, Inc.	2015-12-01
膝关节病变	临床2期	马来西亚	KLSMC Stem Cells, Inc.	2015-12-01
软骨损伤	临床2期	美国	KLSMC Stem Cells, Inc.	2015-12-01
软骨损伤	临床2期	马来西亚	KLSMC Stem Cells, Inc.	2015-12-01

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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


EHA2015	N/A	FLT3-ITD/TKD-突变型血液恶性肿瘤	118	AUTOLOGOUS PERIPHERAL BLOOD CD34+ CRYOPRESERVED WITH 5% DIMETHYL SULFOXIDE COMPARED TO 10% (5% DMSO)	憲蓋繭築願構衊衊遞淵(築壓壓遞憲構鏇糧積衊) = 構鏇簾壓襯淵願觸夢衊觸鑰製鹹繭繭餘繭窪構 (淵獵衊觸襯範鏇簾願廠 ) 更多	-	2015-05-21
				AUTOLOGOUS PERIPHERAL BLOOD CD34+ CRYOPRESERVED WITH 5% DIMETHYL SULFOXIDE COMPARED TO 10% (10% DMSO)	憲蓋繭築願構衊衊遞淵(築壓壓遞憲構鏇糧積衊) = 觸襯衊鬱積壓鹹醖窪鏇觸鑰製鹹繭繭餘繭窪構 (淵獵衊觸襯範鏇簾願廠 ) 更多