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

NCT03180463 | Suspended Phase 1

• 1 other identifier: SCLnow-IMIMH-05
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteonecrosis of Femoral Head

Keywords

Osteonecrosis of Femoral Head; umbilical cord mesenchymal stem cells

Outcome Measures

Primary Outcomes (1)

• MRI imageological examination

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

  6 months

Secondary Outcomes (1)

• Harris Hip Score

  6 months

Study Arms (2)

Group 1

EXPERIMENTAL

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

Drug: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#); Procedure: core decompression

Group 2

PLACEBO COMPARATOR

Core decompression surgery.

Procedure: core decompression

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,

Group 1

core decompression 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 1; Group 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sclnow Biotechnology Co., Ltd.: lead

Study Sites (1)

Inner Mongolia International Mongolian Hospital

Hohhot, Inner Mongolia, 010065, China

Location

MeSH Terms

Conditions

Femur Head Necrosis

Condition Hierarchy (Ancestors)

Osteonecrosis; Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bahushan

  Inner Mongolia International Mongolian Hospital

  STUDY DIRECTOR

• Lei Guo, Dr.

  China-Japan Union Hospital, Jilin University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: June 8, 2017
• Study Start (Estimated): December 31, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 23, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)