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Trial record 3 of 1835 for:    "bone marrow" | Recruiting, Not yet recruiting Studies

Autologous Bone Marrow Concentration for Avascular Necrosis of Femoral Head

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ClinicalTrials.gov Identifier: NCT03787329
Recruitment Status : Recruiting
First Posted : December 26, 2018
Last Update Posted : January 4, 2019
Sponsor:
Collaborator:
Aeon Biotechnology Corporation
Information provided by (Responsible Party):
Pei-Yuan Lee, MD, Show Chwan Memorial Hospital

Tracking Information
First Submitted Date December 22, 2018
First Posted Date December 26, 2018
Last Update Posted Date January 4, 2019
Actual Study Start Date April 14, 2017
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 2, 2019)
3-month postoperative hip function evaluated by Harris Hip Score [ Time Frame: 3-month postoperative ]
Hip function is evaluated using Harris Hip score. The survey has 10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.
Original Primary Outcome Measures
 (submitted: December 22, 2018)
3-month postoperative hip function evaluated by Harris Hip Score [ Time Frame: 3-month postoperative ]
Hip function is evaluated using Harris hip score
Change History
Current Secondary Outcome Measures
 (submitted: January 2, 2019)
  • 6-month postoperative hip function evaluated by Harris Hip Score [ Time Frame: 6-month postoperative ]
    Hip function is evaluated using Harris Hip Score. The survey has 10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.
  • 12-month postoperative hip function evaluated by Harris Hip Score [ Time Frame: 12-month postoperative ]
    Hip function is evaluated using Harris Hip Score. The survey has 10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.
  • 3-month postoperative degree of collapse evaluated by plain radiograph [ Time Frame: 3-month postoperative ]
    Degree of collapse is evaluated by plain radiograph
  • 6-month postoperative degree of collapse evaluated by plain radiograph [ Time Frame: 6-month postoperative ]
    Degree of collapse is evaluated by plain radiograph
  • 12-month postoperative degree of collapse evaluated by plain radiograph [ Time Frame: 12-month postoperative ]
    Degree of collapse is evaluated by plain radiograph
  • 6-month postoperative degree of collapse evaluated by MRI [ Time Frame: 6-month postoperative ]
    Degree of collapse is evaluated by MRI
Original Secondary Outcome Measures
 (submitted: December 22, 2018)
  • 6-month postoperative hip function evaluated by Harris Hip Score [ Time Frame: 6-month postoperative ]
    Hip function is evaluated using Harris Hip Score
  • 12-month postoperative hip function evaluated by Harris Hip Score [ Time Frame: 12-month postoperative ]
    Hip function is evaluated using Harris Hip Score
  • 3-month postoperative degree of collapse evaluated by plain radiograph [ Time Frame: 3-month postoperative ]
    Degree of collapse is evaluated by plain radiograph
  • 6-month postoperative degree of collapse evaluated by plain radiograph [ Time Frame: 6-month postoperative ]
    Degree of collapse is evaluated by plain radiograph
  • 12-month postoperative degree of collapse evaluated by plain radiograph [ Time Frame: 12-month postoperative ]
    Degree of collapse is evaluated by plain radiograph
  • 6-month postoperative degree of collapse evaluated by MRI [ Time Frame: 6-month postoperative ]
    Degree of collapse is evaluated by MRI
  • 12-month postoperative degree of collapse evaluated by MRI [ Time Frame: 12-month postoperative ]
    Degree of collapse is evaluated by MRI
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Autologous Bone Marrow Concentration for Avascular Necrosis of Femoral Head
Official Title The Effect of Autologous Bone Marrow Concentration Combined With Core Decompression for Avascular Necrosis of Femoral Head
Brief Summary This study aims to evaluate the effect of bone marrow concentration on avascular necrosis of femur head by comparing clinical and imaging outcomes between patients receiving core decompression surgery with intraoperative bone marrow concentration and those receiving core decompression surgery only.
Detailed Description Avascular necrosis (AVN) of femoral head is a progressive disease that predominantly affects younger patients. Although the exact pathophysiology of AVN has not yet to be elucidated, the disease is characterized by a vascular insult to the blood supply of the femoral head, which can lead to collapse of the femoral head and subsequent degenerative changes. Mesenchymal stem cells (MSCs) are pluripotent cells that can differentiate into multiple mesenchymal tissues, including tenocytes, chondrocytes and osteoblasts, as well as being a source of multiple growth factors to establish an environment conducive to soft and hard tissue regeneration. As bone marrow concentration has high concentration of mesenchymal stem cells, several studies have applied the autologous bone marrow concentration in halting the progression of AVN of femoral head. However, a higher level of evidence for its use on patients suffering from femoral head avascular necrosis has not been reported. This clinical trial will evaluate and compare the eligible patients who undertake core decompression surgery plus intraoperative bone marrow concentration with those who received core decompression surgery only. All patients will be followed for one year and clinical and imaging outcomes will be compared and analyzed.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population consecutive eligible patients who underwent core decompression combined with autologous bone marrow stem cells treatment for avascular necrosis of the femoral head
Condition
  • Avascular Necrosis of Femur
  • Bone Marrow
Intervention
  • Other: Core decompression surgery with bone marrow concentration
    Core decompression surgery with bone marrow concentration
  • Other: Core decompression surgery
    Core decompression surgery only
Study Groups/Cohorts
  • Bone marrow concentration group
    The patients receive core decompression surgery with bone marrow concentration.
    Intervention: Other: Core decompression surgery with bone marrow concentration
  • Historical control group
    The previous age-, gender-, and stage-matched patients who received core decompression surgery only.
    Intervention: Other: Core decompression surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 2, 2019)
40
Original Estimated Enrollment
 (submitted: December 22, 2018)
20
Estimated Study Completion Date December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age between 30 and 60 years
  • With diagnosis of avascular necrosis of femoral head, Stage I - Stage III

Exclusion Criteria:

  • With diagnosis of avascular necrosis of femoral head, Stage VI - Stage VI
  • With prior history of hip surgery
  • With current or prior history of trauma or infection at hip
  • Platelet count < 50,000/µL
  • With current diagnosis of coagulopathy
  • With current or prior history of cancer
  • With current or prior history of hematological disease
  • Pregnancy
  • Patients who will not cooperate with one-year followup
Sex/Gender
Sexes Eligible for Study: All
Ages 30 Years to 60 Years   (Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Chang-Han Chuang, MD +886-975611794 skyman889@gmail.com
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03787329
Other Study ID Numbers RD-106057
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Pei-Yuan Lee, MD, Show Chwan Memorial Hospital
Study Sponsor Pei-Yuan Lee, MD
Collaborators Aeon Biotechnology Corporation
Investigators
Study Chair: Pei-Yuan Lee, MD Show Chwan Memorial Hospital
PRS Account Show Chwan Memorial Hospital
Verification Date January 2019