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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT03180463
Other study ID # SCLnow-IMIMH-05
Secondary ID
Status Suspended
Phase Phase 1/Phase 2
First received
Last updated
Start date December 31, 2024
Est. completion date December 31, 2025

Study information

Verified date April 2024
Source Sclnow Biotechnology Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Suspended
Enrollment 30
Est. completion date December 31, 2025
Est. primary completion date June 30, 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
China Inner Mongolia International Mongolian Hospital Hohhot Inner Mongolia

Sponsors (1)

Lead Sponsor Collaborator
Sclnow Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary MRI imageological examination MRI imageological examination to evaluate the efficient of mesenchymal stem cells. 6 months
Secondary Harris Hip Score Evaluate curative effects by the change of Harris hip score. 6 months
See also
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Recruiting NCT04266236 - LPB Combined With QLB Using Single-needle Technique (LPQLB-SNT) for Hip Arthroplasty N/A
Completed NCT02735538 - Transcription Factor Runx2 in Necrotic Femoral Head Tissue N/A