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

Sclnow Biotechnology Co., Ltd.30 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Osteonecrosis of Femoral Head

Interventions

Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)DRUG

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

core decompressionPROCEDURE

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Inner Mongolia International Mongolian Hospital

Hohhot, Inner Mongolia, China

Outcomes

Primary Outcomes

MRI imageological examination

MRI imageological examination to evaluate the efficient of mesenchymal stem cells.

Time frame: 6 months

Secondary Outcomes

Harris Hip Score

Evaluate curative effects by the change of Harris hip score.

Time frame: 6 months

Data from ClinicalTrials.gov

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