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临床试验/NCT03066245
NCT03066245Unknown1 期

Autologous Bone Tissue Constructed On Biodegradable Polymer for the Treatment of Aneurysmal Bone Cysts

Sophia Al-Adwan2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2018年5月3日最近更新:
适应症
干预措施

试验速览

阶段
1 期
发起方
入组人数
4
试验地点
2
主要终点
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the MSC-PLGA engraftment

研究概览

简要总结

Patients qualified for this study are those diagnosed with ABCs and failed to be treated with other forms of classical therapies. In which, these patients will be engrafted with biodegradable scaffolds seeded with Mesenchymal Stem Cells (MSCs) supplemented with Platelet lysate.

详细描述

Aneurysmal bone cysts (ABC) are relatively rare, benign, tumor-like, expansile osteolytic lesions of unknown etiology which are predominantly found within the long bones and characterized by frequent idiopathic fractures. Despite the large variety of bone substitutes that have been used to fill these cystic lesions, to date there is no graft material which can be regarded as completely satisfactory, with a recurrence rate that ranges from 5-40% of treated cases. Autologous bone marrow derived mononuclear cells have been used previously to treat ABCs. Poly lactic-co-glycolic acid (PLGA) scaffolds have been used in bone tissue engineering due to their biodegradability and biocompatibility. Human platelet lysate (PL) contains a number of mitogenic growth factors and has been demonstrated to enhance mesenchymal stem cell (MSC) proliferation and expansion rate in vitro. This study is designed to assess the safety and effectiveness of using PLGA scaffolds seeded with autologous bone marrow MSCs and supplemented with osteogenic media and platelet lysate in healing bone lesions of patients suffering from aneurysmal bone cysts. This study will be conducted at the Cell Therapy Center (CTC), Jordan. Four ABC cases will be included. Patients qualified for this study are those diagnosed with ABCs and failed to be treated with other forms of classical therapies; such as allografts or who are not candidate of autografts.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
4 Years 至 28 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Bone cyst diagnosed with MRI, CT-scan, or X-Ray
  • Intact cyst wall with high risk for fracture
  • Cysts with minimum diameter of 6mm
  • Diagnostic test performed on cyst fluid
  • Diagnosed ABC patients whom treatments with other forms of classical therapies ;such as allograft failed or who are not candidate of autografts
  • Provided written consent form

排除标准

  • Patients with diagnosis of cancer
  • Patients enrolled in other clinical trial

研究组 & 干预措施

MSC-PLGA

Experimental

The lesion will be treated with curettage then 1 million of bone marrow derived MSC seeded on 5x5 mm2 PLGA scaffold will be engrafted in the cyst of ABC patient.

干预措施: MSC-PLGA (Biological)

结局指标

主要结局

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the MSC-PLGA engraftment

时间窗: 3 months

The safety of the engraftment will be monitored by assessing any adverse event resulting from the engraftment procedure

次要结局

  • Effectiveness of using PLGA scaffolds seeded with autologous bone marrow MSCs by Radiograph(6 months)

研究者

发起方
Sophia Al-Adwan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sophia Al-Adwan

Researcher, Msc

University of Jordan

研究点 (2)

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