Clinical Study of Umbilical Cord Blood Mononuclear Cells (UCB-MNCs) in the Treatment of Traumatic Fracture Healing

Qianfoshan Hospital

Status: Unknown

Conditions: Bone Nonunion

Treatments: Biological: Umbilical cord blood mononuclear cells; Drug: Staphylococcal Enterotoxin C

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04997590

YXLL-KY-2020(041)

Details and patient eligibility

About

The aim of this study is to explore the effectiveness and safety of umbilical cord blood mononuclear cells in promoting traumatic fracture healing.

Full description

Umbilical cord blood mononuclear cells are a type of cell group containing hematopoietic stem cells, mesenchymal stem cells, neural stem cells, endothelial cells, immune cells, etc.In this study ,umbilical cord blood mononuclear cells will be used in promoting traumatic fracture healing,and the effectiveness and safety of the treatment plan was evaluated by twelve months of follow-up after treatment.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Umbilical cord blood mononuclear cells group

Experimental group

Description:

Umbilical cord blood mononuclear cells (cell number 1×108/2mL), once every two weeks, 3 times in total.

Treatment:

Biological: Umbilical cord blood mononuclear cells

Staphylococcal Enterotoxin C group

Active Comparator group

Description:

Staphylococcal enterotoxin C (2mL), once every two weeks, 3 times in total.

Treatment:

Drug: Staphylococcal Enterotoxin C