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.

NCT03000712 | Completed

• 1 other identifier: HTO-MSCs
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• MRI scan

  MRI perform to measure cartilage defect size change from baseline up to 27 weeks

  24 months

Secondary Outcomes (11)

• MRI scan

  15, 27 weeks, 18, 24 months

• WOMAC score

  15, 27 weeks, 18, 24 months

• WOMAC sub-scale

  15, 27 weeks, 18, 24 months

• Kellgren & Lawrence grade

  15, 27 weeks, 18, 24 months

• EQ5D

  15, 27 weeks, 18, 24 months

Study Arms (2)

Autologous Adipose Tissue derived MSCs

EXPERIMENTAL

Biological: Autologous Adipose Tissue derived MSCs 1x10\^8cells/3ml, 1 time injection(at 1week after high tibial osteotomy)

Biological: Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml

No treatment

NO INTERVENTION

No treatment (after high tibial osteotomy)

Interventions

Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml BIOLOGICAL

biological : Autologous Adipose Tissue derived MSCs 1x10\^8cells/3ml drug: saline solution

Also known as: JOINTSTEM

Autologous Adipose Tissue derived MSCs

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must consent in writing to participate in the study by signing and dating an informed consent document
• between 20 years and 80 years of age
• BMI≤30
• Diagnosis of osteoarthritis by radiographic criteria of Kellgren and Lawrence grade 2-4
• 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
• Patients who agree with contraception
• Patients who agree to stop the existing osteoarthritis treatment and to get enough washout periods until medication time
• Patients scheduled for High tibial osteotomy due to medial gonarthrosis

You may not qualify if:

• patients with osteoporosis
• Preparing for Pregnancy or Pregnant women or lactating mothers.
• Patients with positive human immunodeficiency (HIV), hepatitis B (HBV), hepatitis C (HCV), venereal disease research laboratory(VDRL)
• Patients with hypersensitivity to investigator product or investigational product component or those with a history
• Patients who had participated in other clinical trials within 12 weeks prior to this study
• Patients who received any drug by intra-articular injection for treatment within 2 months prior to this enrollment.
• Patients who experienced as the knee joint cartilage and stem cell therapy or failure to treat
• 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)
• 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
• Patients who have clinically significant severe medical illnesses judged the principal investigator
• Patients who have been diagnosed with malignancy within 5 years before screening (except for patients who were completely remissioned three years before screening criteria)
• Patients who the principal investigator consider inappropriate for the clinical trial due to any other reasons
• Patients who received concomitant contraindications and who have not passed the prescribed wash-out period before participating in the clinical trial

Sponsors & Collaborators

• R-Bio: lead

Study Sites (1)

KyungHee University Gangdong Hospital

Seoul, 134-727, South Korea

Location

Related Publications (1)

• Kim JH, Kim KI, Yoon WK, Song SJ, Jin W. Intra-articular Injection of Mesenchymal Stem Cells After High Tibial Osteotomy in Osteoarthritic Knee: Two-Year Follow-up of Randomized Control Trial. Stem Cells Transl Med. 2022 Jun 22;11(6):572-585. doi: 10.1093/stcltm/szac023.

  PMID: 35674255 DERIVED

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee; Joint Diseases

Condition Hierarchy (Ancestors)

Arthritis; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• KANGIL KIM, M.D., Ph.D

  KyungHee University Gangdong Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2016
• First Posted: December 22, 2016
• Study Start: November 2, 2016
• Primary Completion: May 22, 2020
• Study Completion: May 22, 2020
• Last Updated: January 29, 2021

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)