Bone Nonunion Clinical Trial
Official title:
Clinical Study of Umbilical Cord Blood Mononuclear Cells (UCB-MNCs) in Promoting Traumatic Fracture Healing
The aim of this study is to explore the effectiveness and safety of umbilical cord blood mononuclear cells in promoting traumatic fracture healing.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 10, 2022 |
Est. primary completion date | December 10, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Traumatic long bone fracture. - Noninfectious bone nonunion, delayed bone union. - 3 months after the operation of the fracture, the examination showed no callus growth, no signs of progressive repair at the fracture site, fracture piece space < 5mm. - No shortening, angulation and displacement. - There was no obvious callus growth 8 months after local bone grafting. Exclusion Criteria: - There are infection foci at and near the fracture end after fracture. - 3 months after the fracture, tests showed partial callus growth. - Combining shortening, angulation and displacement phenomena. - Partial callus grew 8 months after local bone grafting. |
Country | Name | City | State |
---|---|---|---|
China | China, Shandong Qianfoshan Hospital | Jinan | Shandong |
Lead Sponsor | Collaborator |
---|---|
Qianfoshan Hospital | Shandong Qilu Stem Cells Engineering Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bone formation | If there is no bone formation, 0 points. Bone formation accounts for 25% of the fracture area, 1 point. Bone formation accounts for 50% of the fracture area, 2 points. Bone formation accounts for 75% of the fracture area, 3 points. Bone filled the gap between fracture ends, 4 points. | 1 month to 1 year after treatment | |
Primary | Bone defect connection | 0 points for complete fracture lines, 2 points for partial fracture lines, 4 points for lack of fracture lines. | 1 month to 1 year after treatment | |
Primary | Bone reconstruction | 0 points for no manifestations of reconstruction,2 points for intramedullary cavity can be reconstructed , and 4 points for the cortical bone can be completely reconstructed. A total score of 11 points or more achieves a good healing effect. | 1 month to 1 year after treatment |
Status | Clinical Trial | Phase | |
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Recruiting |
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