NCT03180463

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

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

• Status: Suspended
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Sclnow Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Osteonecrosis of Femoral Head

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-12-31
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2017-06-08
• Last updated: 2025-05-14

Locations

1 site across 1 country: China