Skip to main content
OpenTrials
Completed

NCT Number: NCT02544802

Mesenchymal Stem Cell Treatment for Primary Osteoarthritis Knee

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Taipei Veterans General Hospital

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Subject infected with hepatitis B, hepatitis C, HIV, syphilis or HTLV.
  • Subject not suitable for liposuction surgery.
  • Subject with hypersensitivity/allergy to anesthetic.
  • Subject's creatinine values higher than 1.6mg/dl.
  • Subject with body mass index, BMI over 30.
  • Subject's studied knee treated with intra-articular injection therapy within 6 months prior to screen.
  • Subject has undergone surgery on either side of knee, including fracture surgery, arthroscopic surgery, meniscus repair surgery, or cruciate ligament reconstruction surgery.
  • Subject enrolled in any other cell therapy studies within the past 30 days.
  • Subject who the investigator considers inappropriate for the clinical trial due to any other reasons than those listed above.
  • Subject has a history of gouty arthritis, septic arthritis, rheumatoid arthritis and any other autoimmune arthritis of the knee joint.
  • Subject has had major medical problems in vital organs, such as; heart, liver, kidney, or lung.

Treatment and study plan

Adipose-Derived Mesenchymal Stem Cells

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Steminent Biotherapeutics Inc.

Industry

Registry information

Official study title

Treatment of Primary Osteoarthritis of the Knee Joint With Autologous Mesenchymal Stem Cells

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Sep 9, 2015
Registry last updated
Oct 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.