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.

NCT ID: NCT03000712

Last Updated: 2021-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-02
• Study Completion Date: 2020-05-22

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.

Conditions

Degenerative Arthritis; Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Autologous Adipose Tissue derived MSCs

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

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

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

No treatment

No treatment (after high tibial osteotomy)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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

Intervention Type: BIOLOGICAL

Other Intervention Names

JOINTSTEM

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

R-Bio

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

KANGIL KIM, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

KyungHee University Gangdong Hospital

Locations

KyungHee University Gangdong Hospital

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 35674255 (View on PubMed)

Other Identifiers

HTO-MSCs

Identifier Type: -

Identifier Source: org_study_id