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Mesenchymal Stem Cell Treatment for Primary Osteoarthritis Knee

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Steminent Biotherapeutics Inc.

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Knee Drug: Adipose-Derived Mesenchymal Stem Cells Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Primary Osteoarthritis of the Knee Joint With Autologous Mesenchymal Stem Cells
Study Start Date : June 2015
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: ADMSCs
Three intra-articular injections of ADMSCs at the dose of 8~10x10^6 cells/injection
Drug: Adipose-Derived Mesenchymal Stem Cells



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Clinical assessment of visual analogue scale (VAS) [ Time Frame: 12 months ]
  2. Clinical assessment of Short Form 36 questionnaire (SF-36) [ Time Frame: 12 months ]
  3. Clinical assessment of Western Ontario and McMaster Universities Arthritis Index (WOMAC) [ Time Frame: 12 months ]
  4. Clinical assessment of Hospital for Special Surgery (HSS) Knee Score [ Time Frame: 12 months ]
  5. Clinical imaging assessment of knee X-ray [ Time Frame: 12 months ]
  6. Clinical imaging assessment of MRI of the knee [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02544802


Locations
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Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Sponsors and Collaborators
Steminent Biotherapeutics Inc.

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Responsible Party: Steminent Biotherapeutics Inc.
ClinicalTrials.gov Identifier: NCT02544802     History of Changes
Other Study ID Numbers: SB-VGH-201102
First Posted: September 9, 2015    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases