NCT02483364已完成2 期
A Phase II Clinical Trial to Assess the Effect of HC-SVT-1001 (Autologous Fat Stem Adult Mesenchymal Cells Expanded and Combined With a Tricalcium Phosphate Biomaterial) and HC-SVT-1002 (Allogeneic Fat Stem Adult Mesenchymal Cells Expanded and Combined With a Tricalcium Phosphate Biomaterial) in the Surgical Treatment of Atrophic Pseudarthrosis of Long Bones
Salvat2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2015年11月10日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Effectiveness by mean of radiological methods on the appearance of signs of osseous setting formation.
研究概览
简要总结
The purpose os this study is to evaluate the safety and effectiveness of HC-SVT-1001 and HC-SVT-1002 in the surgical treatment of atrophic nonunion in long bones.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of either sex between 18 and 65 years of age (both inclusive).
- •Diagnosis of atrophic pseudoarthrosis of long bones confirmed radiographically.
排除标准
- •Present infection (infection signs should not be evidenced).
- •Other lesions which interfere with the body weight load.
- •Open pseudoarthrosis (at the time of inclusion).
- •Congenital bone diseases (hypophosphatemia), metabolic bone disease associated with primary or secondary hypoparathyroidism.
- •Other conditions or circumstances that compromise the study participation according to medical criteria.
结局指标
主要结局
Effectiveness by mean of radiological methods on the appearance of signs of osseous setting formation.
时间窗: Within 6 months after surgery.
Safety of HC-SVT-1001 and HC-SVT-1002 in the surgical treatment of atrophic nonunion in long bones by recording of adverse events.
时间窗: Up to 24 months after surgery.
次要结局
- Comparative statistical analysis(Up to 24 months after surgery.)
研究者
研究点 (2)
Loading locations...
相似试验
撤回
2 期
A Study of the Immunogenicity and Safety of SCTV01C in Population Aged ≥12 Years and Previously Vaccinated With Inactivated COVID-19 VaccineCOVID-19SARS-CoV2 InfectionNCT05239975Sinocelltech Ltd.
Unknown
2 期
A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01C and SCTV01E in Population Aged ≥12 Years Previously Fully Vaccinated With Inactivated COVID-19 VaccineCOVID-19SARS-CoV-2 InfectionNCT05239806Sinocelltech Ltd.400
尚未招募
2 期
A Study to Evaluate the Immunogenicity and Safety of A Recombinant Protein COVID-19 Vaccine as Booster VaccinesCOVID-19SARS-CoV-2 InfectionNCT05933512Sinocelltech Ltd.600
进行中（未招募）
2 期
A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants With Advanced Upper Gastrointestinal Tract MalignanciesGastrointestinal Tract MalignanciesNCT05329766Arcus Biosciences, Inc.332
撤回
2 期
A Study to Evaluate the Immunogenicity and Safety of SCTV01C and SCTV01E (Two Recombinant Protein COVID-19 Vaccines) in Population Aged ≥12 YearsCOVID-19SARS-CoV-2 InfectionNCT05308602Sinocelltech Ltd.