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

NCT ID: NCT03180463

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2026-12-31

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.

Conditions

Osteonecrosis of Femoral Head

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1

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

Group Type: EXPERIMENTAL

Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)

Intervention Type: DRUG

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

core decompression

Intervention Type: PROCEDURE

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.

Group 2

Core decompression surgery.

Group Type: PLACEBO_COMPARATOR

core decompression

Intervention Type: PROCEDURE

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.

Interventions

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,

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sclnow Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bahushan

Role: STUDY_DIRECTOR

Inner Mongolia International Mongolian Hospital

Lei Guo, Dr.

Role: STUDY_CHAIR

China-Japan Union Hospital, Jilin University

Locations

Inner Mongolia International Mongolian Hospital

Hohhot, Inner Mongolia, China

Countries

China

Other Identifiers

SCLnow-IMIMH-05

Identifier Type: -

Identifier Source: org_study_id