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Completed

NCT Number: NCT03007576

Treatment of Knee Osteoarthritis With Autologous Mesenchymal Stromal Cell Product (RegStem)

Osteoarthritis (OA) is a common and incurable disease for the elderly in Taiwan, so it is an important mission to develop a new treatment for OA. Recently, cellular therapy is a new and popular medical treatment around the world, one of them is "Mesenchymal Stromal Cells (MSCs)". MSCs are found in many tissues of human body and play an important role for repairing, regeneration, anti-inflammatory and chondrogenesis. So, MSC product, RegStem, for osteoarthritis treatment becomes a developing target for new generation drugs.

This study is to isolate and expand MSCs(RegStem) from infrapatellar fat pad of subject. When the number of MSCs expands to 1×10^8, cell will be cryopreserved in the liquid nitrogen tank until all release tests passed. On the distribution day, cell will be thawed and injected into joint cavity of patient (5×10^7). Subjects will be monitored after MSC product infusion of seven days, one month, six months and one year. The monitoring items include the changes of knee (by appearance, X-ray and MRI of knee) and pain improvement (by questionnaire).

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Key information

Conditions

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

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Far Eastern Memorial Hospital

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects who understand and sign the informed consent form for this study
  • Grade 2~3 osteoarthritis according to the Kellgren-Lawrence grading scale with one-month X-ray
  • Age is 50~75 years old
  • Postmenopausal women
  • VAS scores in 50 to 90 mm

Exclusion criteria

  • Abnormal of liver and kidney: GOT and GPT > 100 IU/L, BUN >22 mg/dl and creatinine > 1.2 mg/dl.
  • Positive serology for HIV, HTLV-1/2 and syphilis
  • Women who are pregnant or breast feeding
  • Serious pre-existing medical conditions: coagulation disorders, cardiovascular diseases (arrhythmias, myocardial infarction and surgery), renal diseases (chronic renal failure), liver diseases (cirrhosis), diabetes mellitus type I, cancer history.
  • Other joint diseases: knee deformity (knee varus greater than 10 degree or valgus greater than 20 degree), rheumatic arthritis, gouty arthritis, septic arthritis, serious meniscal tear, other autoimmune arthritis.
  • Skin inflammatory of knee
  • Knee pain caused by referred pain from spine disease or hip joint disease. Knee pain combined with pain from spine disease or hip disease.
  • Immunosuppressive state
  • Subjects who were injected with hyaluronic acid and PRP in the past 6 months
  • Body mass index (BMI) greater than 30
  • Have a history of allergic reaction of any medication
  • Participation in another clinical trial or treatment within 3 months
  • Other pathologic conditions or circumstances that difficult participation in this study according to PI's evaluations

Treatment and study plan

RegStem

Biological

RegStem, 1.5 ml, one injection

Other names: MSC

Primary outcomes

  1. Safety of RegStem by incidence of adverse events and changes in physical examinations, vital signs and the results of clinical lab tests.

    Time frame: 48 weeks

  2. Clinical assessment of International Knee Documentation Committee (IKDC) score

    Time frame: 48 weeks

    Assess symptoms of knee, sport activity and function of knee

Secondary outcomes

  1. Clinical assessment of Knee injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: 48 weeks

  2. Clinical assessment of visual analogue scale (VAS)

    Time frame: 48 weeks

  3. Clinical assessment of knee X-ray

    Time frame: 48 weeks

  4. Clinical assessment of knee MRI

    Time frame: 48 weeks

Sponsors and collaborators

Lead sponsor

EMO Biomedicine Corporation

Industry

Collaborators

  • Far Eastern Memorial Hospital

Registry information

Official study title

Phase I Clinical Trial - Treatment of Knee Osteoarthritis With Autologous Mesenchymal Stromal Cell Product (RegStem)

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 2, 2017
Registry last updated
Nov 13, 2019

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.

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