Clinical trial NCT01300598: Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Degenerative Arthritis
Official title: Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Degenerative Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Degenerative Arthritis
Lead sponsor: R-Bio
Sponsor class: INDUSTRY
First posted: 2011-02-21
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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 degenerative arthritis.

Detailed description: degenerative arthritis is the most common type of arthritis. It is estimated that 26.9 million Americans 25 years old or older have clinical degenerative arthritis of some joints, with a higher percentage of affliction in the older population. Its clinical manifestations include joint pain and impairment to movement, and surrounding tissues are often affected with local inflammation. The etiology of degenerative arthritis is not completely understood; however, injury, age, and genetics have been considered among the risk factors.

Degenerative arthritis is a progressively debilitating disease that affects mostly cartilage, with associated changes in bone. Cartilage has limited intrinsic healing and regenerative capacities.

Due to the increasing incidence of degenerative arthritis and the aging population coupled with inefficient therapeutic choices, novel cartilage repair strategies are in need.

The availability of large quantities of MSCs and their potential for ready chondrogenic differentiation after prolonged in vitro expansion have made MSCs the most hopeful candidate progenitor cell source for cartilage tissue engineering.

In the clinical study, mesenchymal stem cells will be isolated from adipose tissue and cultured, and administered into the cartilage tissue lesion by orthopedic surgery.

It will be stimulate the regeneration of defective cartilage tissue and to improve their functions.

Eligibility criteria: Inclusion Criteria:

* Subjects who understand and sign the consent form for this study.
* Age :18-75, males and females.
* Clinical diagnosis of degenerative arthritis by Radiographic Criteria of Kellgren and Lawrence.
* Patients who can't treat with traditional medication and need a arthroplasty.
* Patients whose lesion is 2\~6 cm2 in size.
* Duration of pain over Grade 4(11-point numeric scale) : \> 4 months

Exclusion Criteria:

* Women who are pregnant or breast feeding or planning to become pregnant during the study.
* Objects who administer with a anti-inflammatory drugs contain herbal medicine within 14 days prior to inclusion in the study.
* History or current evidence of alcohol or drug abuse or is a recreational user of illicit drugs or prescription medications.
* Treatment with intra-articular injection therapy within 2 months prior to screen.
* Other joint diseases except degenerative arthritis : systemic or rheumatic or inflammatory chondropathy, chondrocalcinosis, hemachromatosis, inflammatory joint disease, avascular necrosis of the femoral head, Paget's disease, hemophilic arthropathy, infectional arthritis, Charcot's disease, villonodular synovitis, synovial chondromatosis.
* Positive serology for HIV-1 orHIV-2, Hepatitis B (HBsAg, Anti-HCV-Ab), Hepatitis C (Anti-HCV-Ab) and syphilis.
* Serious pre-existing medical conditions like Cardiovascular Diseases, Renal Diseases, Liver Diseases, Endocrine Diseases, Cancer and Diabetes Mellitus.
* Overweight expressed as body mass index (BMI) greater than 30 (obesity grade II). BMI estimated as mass (kg) / corporal surface (m2).
* Participation in another clinical trial or treatment with a different investigational product within 3 months prior to inclusion in the study.
* Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria.

Primary outcomes:
measure: Safety evaluation
timeFrame: 24 weeks
measure: WOMAC(Western Ontario and McMaster Universities) Index
timeFrame: 24 weeks
Secondary outcomes:
measure: Magnetic Resonance Imaging
timeFrame: 24 weeks
measure: KSCRS(Knee Society Clinical rating System)
timeFrame: 24 weeks
measure: VAS(11-point box visual analogue scale)
timeFrame: 24 weeks
measure: Histological evaluates
timeFrame: 24 weeks
Other outcomes:
measure: cartilage volume of the knee joint
timeFrame: 24 weeks
measure: Arthroscopy
timeFrame: 24 weeks
measure: X-ray
timeFrame: 24 weeks
Locations:
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Hospital
Study officials:
affiliation: SMG-SNU Boramae Hospital
name: Kang Sup Yoon, M.D. & Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jo CH, Lee YG, Shin WH, Kim H, Chai JW, Jeong EC, Kim JE, Shim H, Shin JS, Shin IS, Ra JC, Oh S, Yoon KS. Intra-articular injection of mesenchymal stem cells for the treatment of osteoarthritis of the knee: a proof-of-concept clinical trial. Stem Cells. 2014 May;32(5):1254-66. doi: 10.1002/stem.1634.
citation: Jo CH, Chai JW, Jeong EC, Oh S, Shin JS, Shim H, Yoon KS. Intra-articular Injection of Mesenchymal Stem Cells for the Treatment of Osteoarthritis of the Knee: A 2-Year Follow-up Study. Am J Sports Med. 2017 Oct;45(12):2774-2783. doi: 10.1177/0363546517716641. Epub 2017 Jul 26.