Clinical trial NCT02658344: Clinical Trial to Evaluate Efficacy and Safety of JOINTSTEM in Patients With Degenerative Arthritis
Official title: Multicenter, Randomized, Double-Blind, Placebo Controlled Phase Ⅱb Clinical Trial to Evaluate Efficacy and Safety of JOINTSTEM in Patients With Degenerative Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Degenerative Arthritis
Knee Osteoarthritis
Keywords: Stem cell
adipose tissue derived mesenchymal stem cell
osteoarthritis
degenerative arthritis
biostar
Rbio
Lead sponsor: R-Bio
Sponsor class: INDUSTRY
First posted: 2016-01-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
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 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.

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 -

Primary outcomes:
measure: WOMAC score
timeFrame: 24 weeks
Secondary outcomes:
measure: WOMAC 3 subscale
timeFrame: 24 weeks
measure: KOOS (Knee Injury & Osteoarthritis Outcome Score)
timeFrame: 24 weeks
measure: SF(Short Form)-36 Score
timeFrame: 24 weeks
measure: Global assessment of disease activity
timeFrame: 24 weeks
measure: Overall satisfaction
timeFrame: 24 weeks
measure: X-ray
timeFrame: 24 weeks
measure: MRI scan
timeFrame: 24 weeks
measure: Arthroscopy evaluation
timeFrame: 24 weeks
measure: Histological evaluation
timeFrame: 24 weeks
measure: VAS
timeFrame: 24 weeks
measure: IKDC
timeFrame: 24 weeks
measure: ROM
timeFrame: 24 weeks
measure: Quadriceps power
timeFrame: 24 weeks
measure: effusion
timeFrame: 24 weeks
measure: Crepitus
timeFrame: 24 weeks
measure: Ligament laxity
timeFrame: 24 weeks
measure: Medial joint line tenderness
timeFrame: 24 weeks
measure: Pes tenderness
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: KyungHee University Gangdong Hospital
city: Seoul
country: Korea, Republic of
facility: GangNam Severance Hospital
Study officials:
affiliation: KyungHee University Gangdong Hospital
name: KANGIL KIM, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.