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

April 22, 2026 updated by: Sclnow Biotechnology Co., Ltd.

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China, 010065
        • Inner Mongolia International Mongolian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Core decompression surgery; Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#).
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.
Placebo Comparator: Group 2
Core decompression surgery.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sclnow Biotechnology Co., Ltd.

Investigators

  • Study Director: Bahushan, Inner Mongolia International Mongolian Hospital
  • Study Chair: Lei Guo, Dr., China-Japan Union Hospital, Jilin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 31, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

June 6, 2017

First Submitted That Met QC Criteria

June 6, 2017

First Posted (Actual)

June 8, 2017

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCLnow-IMIMH-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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