Clinical Study of Umbilical Cord Blood Mononuclear Cells (UCB-MNCs) in the Treatment of Traumatic Fracture Healing
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|ClinicalTrials.gov Identifier: NCT04997590|
Recruitment Status : Recruiting
First Posted : August 9, 2021
Last Update Posted : August 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|Bone Nonunion||Biological: Umbilical cord blood mononuclear cells Drug: Staphylococcal Enterotoxin C||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study of Umbilical Cord Blood Mononuclear Cells (UCB-MNCs) in Promoting Traumatic Fracture Healing|
|Actual Study Start Date :||December 10, 2020|
|Estimated Primary Completion Date :||December 10, 2021|
|Estimated Study Completion Date :||December 10, 2022|
Experimental: Umbilical cord blood mononuclear cells group
Umbilical cord blood mononuclear cells (cell number 1×108/2mL), once every two weeks, 3 times in total.
Biological: Umbilical cord blood mononuclear cells
injection of CB-MNCs (cell count 1×108 cells/time) was performed once every 2 week for a total of 3 times.
Active Comparator: Staphylococcal Enterotoxin C group
Staphylococcal enterotoxin C (2mL), once every two weeks, 3 times in total.
Drug: Staphylococcal Enterotoxin C
injection of staphylococcal enterotoxin C was performed once every 2 week for a total of 3 times.
- Bone formation [ Time Frame: 1 month to 1 year after treatment ]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.
- Bone defect connection [ Time Frame: 1 month to 1 year after treatment ]0 points for complete fracture lines, 2 points for partial fracture lines, 4 points for lack of fracture lines.
- Bone reconstruction [ Time Frame: 1 month to 1 year after treatment ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04997590
|Contact: Chunming Zhang, email@example.com|
|China, Shandong Qianfoshan Hospital||Recruiting|
|Jinan, Shandong, China, 250014|
|Contact: Lili Cao firstname.lastname@example.org|
|Principal Investigator:||Jing Liang, doctor||Qianfoshan Hospital|