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

Osteonecrosis of Femoral Head Clinical Trial

Official title:

The Study of Early Stage Osteonecrosis of Femoral Head With Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSC)

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03180463
• Other study ID #: SCLnow-IMIMH-05
• Status: Suspended
• Phase: Phase 1/Phase 2
• Start date: December 31, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Sclnow Biotechnology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Femur Head Necrosis
• Osteonecrosis
• Osteonecrosis of Femoral Head

Intervention

Drug:
• Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)
Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) will be injected through surgery tunnel, 2*10^7 cells,

Procedure:
• core decompression
The surgery will drill into the femoral neck (hip bone) and through the necrotic area of the bone that died from the lack of blood flow, take out partial osseous tissue.

Locations

Country	Name	City	State
China	Inner Mongolia International Mongolian Hospital	Hohhot	Inner Mongolia

Sponsors (1)

Lead Sponsor	Collaborator
Sclnow Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI imageological examination	MRI imageological examination to evaluate the efficient of mesenchymal stem cells.	6 months
Secondary	Harris Hip Score	Evaluate curative effects by the change of Harris hip score.	6 months