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Trial record 84 of 806 for:    Interventional Studies | mesenchymal

The Study of Early Stage Osteonecrosis of Femoral Head With Human Umbilical Cord Mesenchymal Stem Cells

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ClinicalTrials.gov Identifier: NCT03180463
Recruitment Status : Not yet recruiting
First Posted : June 8, 2017
Last Update Posted : June 9, 2017
Sponsor:
Information provided by (Responsible Party):
Sclnow Biotechnology Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Osteonecrosis of Femoral Head Drug: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) Procedure: core decompression Phase 1 Phase 2

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
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Study of Early Stage Osteonecrosis of Femoral Head With Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSC)
Estimated Study Start Date : July 2017
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteonecrosis

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.




Primary Outcome Measures :
  1. MRI imageological examination [ Time Frame: 6 months ]
    MRI imageological examination to evaluate the efficient of mesenchymal stem cells.


Secondary Outcome Measures :
  1. Harris Hip Score [ Time Frame: 6 months ]
    Evaluate curative effects by the change of Harris hip score.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03180463


Contacts
Contact: Lei Guo 861064368977 georgeguo@sclnow.com

Locations
China, Inner Mongolia
Inner Mongolia International Mongolian Hospital
Hohhot, Inner Mongolia, China, 010065
Sponsors and Collaborators
Sclnow Biotechnology Co., Ltd.
Investigators
Study Director: Bahushan Inner Mongolia International Mongolian Hospital
Study Chair: Lei Guo, Dr. China-Japan Union Hospital, Jilin University

Responsible Party: Sclnow Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03180463     History of Changes
Other Study ID Numbers: SCLnow-IMIMH-05
First Posted: June 8, 2017    Key Record Dates
Last Update Posted: June 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sclnow Biotechnology Co., Ltd.:
Osteonecrosis of Femoral Head
umbilical cord mesenchymal stem cells

Additional relevant MeSH terms:
Osteonecrosis
Femur Head Necrosis
Bone Diseases
Musculoskeletal Diseases
Necrosis
Pathologic Processes