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

Phase 1

Suspended

• Conditions: Osteonecrosis of Femoral Head
• Interventions: Drug: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#); Procedure: core decompression

• Registration Number: NCT03180463
• Lead Sponsor: Sclnow Biotechnology Co., Ltd.

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-06-06
• Study First Submitted QC: 2017-06-06
• Study First Posted: 2017-06-08
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-14
• Study Start: 2025-12-31
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)	Core decompression surgery; Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#).
Group 1	core decompression	Core decompression surgery; Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#).
Group 2	core decompression	Core decompression surgery.

Primary Outcome Measures

Name	Time	Method
MRI imageological examination	6 months	MRI imageological examination to evaluate the efficient of mesenchymal stem cells.

Secondary Outcome Measures

Name	Time	Method
Harris Hip Score	6 months	Evaluate curative effects by the change of Harris hip score.

Trial Locations

Locations (1)

Inner Mongolia International Mongolian Hospital; 🇨🇳 Hohhot, Inner Mongolia, China