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Mesenchymal Stem Cell Treatment for Primary Osteoarthritis Knee

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02544802
Recruitment Status : Unknown
Verified April 2016 by Steminent Biotherapeutics Inc..
Recruitment status was:  Active, not recruiting
First Posted : September 9, 2015
Last Update Posted : April 20, 2016
Information provided by (Responsible Party):
Steminent Biotherapeutics Inc.

Tracking Information
First Submitted Date  ICMJE September 4, 2015
First Posted Date  ICMJE September 9, 2015
Last Update Posted Date April 20, 2016
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2015)
Safety of intra-articular injection of autologous ADMSCs by incidence of adverse events and alterations in vital signs, blood chemistry profiles, complete blood count, urinalysis, and also the physical examination of the knees. [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02544802 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2015)
  • Clinical assessment of visual analogue scale (VAS) [ Time Frame: 12 months ]
  • Clinical assessment of Short Form 36 questionnaire (SF-36) [ Time Frame: 12 months ]
  • Clinical assessment of Western Ontario and McMaster Universities Arthritis Index (WOMAC) [ Time Frame: 12 months ]
  • Clinical assessment of Hospital for Special Surgery (HSS) Knee Score [ Time Frame: 12 months ]
  • Clinical imaging assessment of knee X-ray [ Time Frame: 12 months ]
  • Clinical imaging assessment of MRI of the knee [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Mesenchymal Stem Cell Treatment for Primary Osteoarthritis Knee
Official Title  ICMJE Treatment of Primary Osteoarthritis of the Knee Joint With Autologous Mesenchymal Stem Cells
Brief Summary The purpose of this study is to evaluate the safety and preliminary efficacy of autologous adipose-derived mesenchymal stem cells (ADMSCs) treatment for patients with primary osteoarthritis knee. Three intra-articular injections of autologous ADMSCs will be performed to subjects at a weekly interval.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis Knee
Intervention  ICMJE Drug: Adipose-Derived Mesenchymal Stem Cells
Study Arms  ICMJE Experimental: ADMSCs
Three intra-articular injections of ADMSCs at the dose of 8~10x10^6 cells/injection
Intervention: Drug: Adipose-Derived Mesenchymal Stem Cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: April 18, 2016)
Original Estimated Enrollment  ICMJE
 (submitted: September 6, 2015)
Estimated Study Completion Date  ICMJE July 2017
Estimated Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject has bilateral Kellgren and Lawrence grade II-III primary osteoarthritis as determined by X-ray.
  2. Subject's pain score is 8-13 points (Lequesne's index).
  3. Ages between 50-70 years.
  4. Signed informed consent from the subject.
  5. Female subjects should be post-menopausal women

Exclusion Criteria:

  1. Subject infected with hepatitis B, hepatitis C, HIV, syphilis or HTLV.
  2. Subject not suitable for liposuction surgery.
  3. Subject with hypersensitivity/allergy to anesthetic.
  4. Subject's creatinine values higher than 1.6mg/dl.
  5. Subject with body mass index, BMI over 30.
  6. Subject's studied knee treated with intra-articular injection therapy within 6 months prior to screen.
  7. Subject has undergone surgery on either side of knee, including fracture surgery, arthroscopic surgery, meniscus repair surgery, or cruciate ligament reconstruction surgery.
  8. Subject enrolled in any other cell therapy studies within the past 30 days.
  9. Subject who the investigator considers inappropriate for the clinical trial due to any other reasons than those listed above.
  10. Subject has a history of gouty arthritis, septic arthritis, rheumatoid arthritis and any other autoimmune arthritis of the knee joint.
  11. Subject has had major medical problems in vital organs, such as; heart, liver, kidney, or lung.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02544802
Other Study ID Numbers  ICMJE SB-VGH-201102
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Steminent Biotherapeutics Inc.
Study Sponsor  ICMJE Steminent Biotherapeutics Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Steminent Biotherapeutics Inc.
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP