The Study of Early Stage Osteonecrosis of Femoral Head With Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-ONFH)

Sclnow Biotechnology

Status and phase: Suspended; Phase 2; Phase 1

Conditions: Osteonecrosis of Femoral Head

Treatments: Procedure: core decompression; Drug: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03180463

SCLnow-IMIMH-05

Details and patient eligibility

About

The purposes of the study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSC) in treating osteonecrosis of femoral head patients.

Full description

This is a randomized,double-blind, paralleled study. Patients will be divided into two groups of experiment and control. All of them will receive core decompression of the femoral head, while experimental group patient will transplant hUC-MSC in addition. Follow-up visit will occur on 1 month, 3 months, and 6 months after operation, and Harris Hip score was applied to evaluate the symptoms change.

Enrollment: 30 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ficat classification is I, IIa, or IIb period
• no obvious improvement or ingravescence by conservative treatment
• patients or their statutory receive human umbilical cord mesenchymal stem cell of their own will, and signed informed consent form

Exclusion criteria

• Ficat classification is third or fourth period
• acute, chronic infection patients
• combined with heart, lung, kidney disease, and cannot tolerate operation
• ankylosing spondylitis patient
• acetabular dysplasia patient
• with tumor
• clinical data deficient
• HIV positive
• pregnancy or breast feeding women
• under other therapy that possibly influence MSC security or efficacy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Group 1

Experimental group

Description:

Core decompression surgery; Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#).

Treatment:

Drug: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)

Procedure: core decompression

Group 2

Placebo Comparator group

Description:

Core decompression surgery.

Treatment:

Procedure: core decompression