Clinical Trial to Evaluate Efficacy and Safety of JOINTSTEM in Patients With Degenerative Arthritis

NCT ID: NCT02658344

Last Updated: 2019-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-12-31

Brief Summary

The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with Knee Osteoarthritis.

Detailed Description

JOINTSTEM is an OA treatment that uses autologous adipose-derived mesenchymal stem cells. As it does not use allogenic tissues 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 improve pain and joint function, and secondary, to regenerate cartilage. The intra-articular injection of JOINTSTEM is expected to stimulate the regeneration and growth of cartilage, and to innovatively improve pain and joint function with cartilage regeneration within six months.

The subjects of this therapy were regenerative patients with K&L grade 2~4 aged 18 or older. JOINTSTEM is expected to be used in patients who have significantly damage cartilage due to its cartilage regeneration ability, in addition to its improvement of pain and joint performance. A;sp. Patients who had already undergone knee arthroplasty can delay their additional surgery with the use of JOINTSTEM. For dose who still have their own cartilage, arthroplasty is not an immediate treatment option, and osteoporosis patients who cannot undergo arthroplasty due to their advanced age can receive JOINTSTEM.

Conditions

Degenerative Arthritis; Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Jointstem

Autologous Adipose Tissue derived MSCs

Group Type: EXPERIMENTAL

JOINTSTEM

Intervention Type: BIOLOGICAL

Jointstem (Autologous Adipose Tissue derived MSCs 1x10\^8cells/3ml), 1 time injection

Saline solution

Sodium chloride

Group Type: PLACEBO_COMPARATOR

Saline solution

Intervention Type: DRUG

Saline solution (Sodium chloride 9mg/ml), 1 time injection

Interventions

JOINTSTEM

Jointstem (Autologous Adipose Tissue derived MSCs 1x10\^8cells/3ml), 1 time injection

Intervention Type: BIOLOGICAL

Saline solution

Saline solution (Sodium chloride 9mg/ml), 1 time injection

Intervention Type: DRUG

Other Intervention Names

Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml; Sodium chloride 9mg/ml

Eligibility Criteria

Inclusion Criteria

1. Age 18 and older, male and female

2. Patients must consent in writing to participate in the study by signing and dating an informed consent document

3. Diagnosis of osteoarthritis by ACR osteoarthritis of the knee

4. Diagnosis of osteoarthritis by radiographic criteria of Kellgren and Lawrence grade 2-4

5. More than Grade 4 (0~10 point numeric scale) pain at least for 12 weeks

6. Diagnosis of osteoarthritis of class Ⅰ~Ⅲ by ACR(American College of Rheumatology Criteria) Global functional criteria

7. Patient who agree with contraception

Exclusion Criteria

1. Preparing for Pregnancy or Pregnant women or lactating mothers.

2. Patients with Body Mass Index (BMI) > 35.

3. Patients with other disease including

: Septic arthritis, Rheumatoid or Inflammatory joint disease, Crystalline disease (gout or pseudogout), Paget disease, Articular fractures, Ochronosis, Acromegaly, Hemochromatosis, Wilson's disease, Osteochondromatosis, Hereditary disorder

4. Patients with serious condition internal medicine disease

5. Patients with positive human immunodeficiency (HIV), hepatitis B (HBV), hepatitis C (HCV), syphilis at screening indicative of current of pass infection.

6. Patient with behavioral disorders, cognitive disorders and chronic mental symptoms

7. Patient with significant neurologic or psychiatric disorders

8. Patients who alcohol, drug abuse history

9. Patients who had participated in other clinical trials within 12 weeks prior to this study.

10. Patients who received any drug by intra-articular injection for treatment within 2 months prior to this enrollment.

11. Patients who experienced as the knee joint cartilage and stem cell therapy

12. Patients who the principal investigator considers inappropriate for the clinical trial due to any other reasons than those listed above

13. Patients who penicillin hypersensitivity reactions -

• Minimum Eligible Age: 18 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

GangNam Severance Hospital

Seoul, , South Korea

Countries

South Korea

References

Lee WS, Kim HJ, Kim KI, Kim GB, Jin W. Intra-Articular Injection of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis: A Phase IIb, Randomized, Placebo-Controlled Clinical Trial. Stem Cells Transl Med. 2019 Jun;8(6):504-511. doi: 10.1002/sctm.18-0122. Epub 2019 Mar 5.

Reference Type: RESULT

PMID: 30835956 (View on PubMed)

Other Identifiers

Jointstem2b

Identifier Type: -

Identifier Source: org_study_id