Clinical trial NCT03000712: Investigator Initiated Trial to Evaluate the Efficacy and Safety of Intra-articular Injection of ADMSC Comared to Negative Control After High Tibial Osteotomy in the Osteoarthritis Patients.
Official title: Single-center, Randomized, Open Label, Negative-controlled Investigator Initiated Trial to Evaluate the Efficacy and Safety of Intra-articular Injection of ADMSC(Autologous Adipose Tissue Derived Mesenchymal Stem Cells) After High Tibial Osteotomy Compared to Negative Control in the Osteoarthritis Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Arthritis
Knee Osteoarthritis
Keywords: adipose tissue derived mesenchymal stem cell
osteoarthritis
degenerative arthritis
kyung hee university hospital
biostar
Rbio
Osteoarthritis, Knee
High tibial osteotomy
Joint Diseases
Lead sponsor: R-Bio
Sponsor class: INDUSTRY
First posted: 2016-12-22
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of intra-articular injection of autologous adipose tissue derived mesenchymal stem cells compared after high tibial osteotomy to negative control in the osteoarthritis patients

Detailed description: In this clinical trial, the investigational product is administered intra-articularly at 1 week after high tibial osteotomy in a patient with degenerative arthritis of the medial side.

The investigational product is autologous adipose-derived mesenchymal stem cells. As it does not use allogenic tissue and is incubated without additional genetic modification or mechanical and chemical modification through differentiation, it is classified as 'autologous cell therapy' and is completely free of immunologic rejection.

It primarily aims to regenerate cartilage, to improve pain and joint function. The intra-articular injection of the investigational product is expected to stimulate the regeneration and growth of cartilage, and to innovatively improve pain and joint function with cartilage regeneration compared to high tibial osteotomy alone.

Eligibility criteria: Inclusion Criteria:

1. Patients must consent in writing to participate in the study by signing and dating an informed consent document
2. Patients who can communicate (exclusion of anyone who cannot understand the questionnaire)
3. between 20 years and 80 years of age
4. BMI≤30
5. Diagnosis of osteoarthritis by radiographic criteria of Kellgren and Lawrence grade 2-4
6. Diagnosis of osteoarthritis by ACR(American College of Rheumatology Criteria) Global functional criteria : There is the pain of the knee and radiographic osteophyte and at least one of the following (1) age \>50 years (2) Less than 30 minutes of morning stiffness (3) The friction When moving weighted the knee
7. Patients who agree with contraception
8. Patients who agree to stop the existing osteoarthritis treatment and to get enough washout periods until medication time
9. Patients scheduled for High tibial osteotomy due to medial gonarthrosis

Exclusion Criteria:

1. patients with osteoporosis
2. Preparing for Pregnancy or Pregnant women or lactating mothers.
3. Patients with positive human immunodeficiency (HIV), hepatitis B (HBV), hepatitis C (HCV), venereal disease research laboratory(VDRL)
4. Patients with hypersensitivity to investigator product or investigational product component or those with a history
5. Patients who had participated in other clinical trials within 12 weeks prior to this study
6. Patients who received any drug by intra-articular injection for treatment within 2 months prior to this enrollment.
7. Patients who experienced as the knee joint cartilage and stem cell therapy or failure to treat
8. Patents who started or changed the physical therapy program established within 2 weeks before the start of the study or during the study(An established physical therapy program may continue for the duration of the trial, provided that it does not change in frequency and intensity)
9. Patents included in the following specific risk groups that may influence safety and efficacy assessments at the discretion of the investigator:: septic arthtritis, rheumatic disease, gout, recurrent pseudogout, paget disease, joint fracture, alcaptonuria, acromegaly, hemochromatosis, wilson's disease, primary osteochondrosis, hereditary disorder(ex: hyperkinesia), collagen gene abnormality ,etc
10. Patients who have clinically significant severe medical illnesses judged the principal investigator
11. Patients who have been diagnosed with malignancy within 5 years before screening (except for patients who were completely remissioned three years before screening criteria)
12. Patients who the principal investigator consider inappropriate for the clinical trial due to any other reasons
13. Patients who received concomitant contraindications and who have not passed the prescribed wash-out period before participating in the clinical trial

Primary outcomes:
measure: MRI scan
timeFrame: 24 months
Secondary outcomes:
measure: MRI scan
timeFrame: 15, 27 weeks, 18, 24 months
measure: WOMAC score
timeFrame: 15, 27 weeks, 18, 24 months
measure: WOMAC sub-scale
timeFrame: 15, 27 weeks, 18, 24 months
measure: Kellgren & Lawrence grade
timeFrame: 15, 27 weeks, 18, 24 months
measure: EQ5D
timeFrame: 15, 27 weeks, 18, 24 months
measure: ROM
timeFrame: 15, 27 weeks, 18, 24 months
measure: KOOS (Knee Injury & Osteoarthritis Outcome Score)
timeFrame: 15, 27 weeks, 18, 24 months
measure: PGIC(Patient Global Impression of Change)
timeFrame: 15, 27 weeks, 18, 24 months
measure: PSQI(Pittsburgh Sleep Quality Index)
timeFrame: 15, 27 weeks, 18, 24 months
measure: Biomarkers
timeFrame: 15, 27 weeks, 18, 24 months
measure: Incidence of adverse reactions and characteristics associated with investigational product
timeFrame: 15, 27 weeks, 18, 24 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: KyungHee University Gangdong Hospital
Study officials:
affiliation: KyungHee University Gangdong Hospital
name: KANGIL KIM, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: