The Study of Early Stage Osteonecrosis of Femoral Head With Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-ONFH)
Primary Purpose
Osteonecrosis of Femoral Head
Status
Suspended
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)
core decompression
Sponsored by
About this trial
This is an interventional treatment trial for Osteonecrosis of Femoral Head focused on measuring Osteonecrosis of Femoral Head, umbilical cord mesenchymal stem cells
Eligibility Criteria
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
Sites / Locations
- Inner Mongolia International Mongolian Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group 1
Group 2
Arm Description
Core decompression surgery; Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#).
Core decompression surgery.
Outcomes
Primary Outcome Measures
MRI imageological examination
MRI imageological examination to evaluate the efficient of mesenchymal stem cells.
Secondary Outcome Measures
Harris Hip Score
Evaluate curative effects by the change of Harris hip score.
Full Information
NCT ID
NCT03180463
First Posted
June 6, 2017
Last Updated
April 11, 2023
Sponsor
Sclnow Biotechnology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03180463
Brief Title
The Study of Early Stage Osteonecrosis of Femoral Head With Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-ONFH)
Official Title
The Study of Early Stage Osteonecrosis of Femoral Head With Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSC)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Suspended
Why Stopped
Others
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sclnow Biotechnology Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteonecrosis of Femoral Head
Keywords
Osteonecrosis of Femoral Head, umbilical cord mesenchymal stem cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Core decompression surgery; Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#).
Arm Title
Group 2
Arm Type
Placebo Comparator
Arm Description
Core decompression surgery.
Intervention Type
Drug
Intervention Name(s)
Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)
Intervention Description
Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) will be injected through surgery tunnel, 2*10^7 cells,
Intervention Type
Procedure
Intervention Name(s)
core decompression
Intervention Description
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.
Primary Outcome Measure Information:
Title
MRI imageological examination
Description
MRI imageological examination to evaluate the efficient of mesenchymal stem cells.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Harris Hip Score
Description
Evaluate curative effects by the change of Harris hip score.
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bahushan
Organizational Affiliation
Inner Mongolia International Mongolian Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lei Guo, Dr.
Organizational Affiliation
China-Japan Union Hospital, Jilin University
Official's Role
Study Chair
Facility Information:
Facility Name
Inner Mongolia International Mongolian Hospital
City
Hohhot
State/Province
Inner Mongolia
ZIP/Postal Code
010065
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Study of Early Stage Osteonecrosis of Femoral Head With Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-ONFH)
We'll reach out to this number within 24 hrs