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

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03180463

Enrollment

Registered

2017-06-08

Start date

2025-12-31

Completion date

2026-12-31

Last updated

2025-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteonecrosis of Femoral Head

Keywords

Osteonecrosis of Femoral Head, umbilical cord mesenchymal stem cells

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.

Interventions

DRUGAllogeneic 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,

PROCEDUREcore 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
MRI imageological examination	6 months	MRI imageological examination to evaluate the efficient of mesenchymal stem cells.

Secondary

Measure	Time frame	Description
Harris Hip Score	6 months	Evaluate curative effects by the change of Harris hip score.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026