Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Degenerative Arthritis

Degenerative Arthritis Clinical Trial

Official title:

Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Degenerative Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01300598
• Other study ID #: Jointstem
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 2008
• Est. completion date: March 2012

Study information

• Verified date: June 2019
• Source: R-Bio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Degenerative Arthritis
• Osteoarthritis

Intervention

Procedure:
• Autologous Adipose Tissue derived MSCs Transplantation
Intra-articular infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 1x10e7 cells/3mL,5x10e7 cells/3mL, 1x10e8 cells/3mL

Locations

Country	Name	City	State
Korea, Republic of	SMG-SNU Boramae Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
R-Bio

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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: 10.1177/0363546517716 — View 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. 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	cartilage volume of the knee joint	changes of the cartilage volume of the knee joint measure using a semi-automated segmentation method by a blinded researcher (webappendix)	24 weeks
Other	Arthroscopy	Arthroscopy performs to evaluate any change in cartilage defect at the time of cell injection, and at 6 months after injection	24 weeks
Other	X-ray	X-ray perform to measure with Kellgren-Lawrence grade,20 joint space width of the medial compartment,21 mechanical axis with weight bearing line,22 and anatomical axis.	24 weeks
Primary	Safety evaluation	To determine the overall safety of RNL-JointStem® carrier using physical examinations, vital signs, treatment emergent adverse events (TEAEs), and the results of clinical lab tests.	24 weeks
Primary	WOMAC(Western Ontario and McMaster Universities) Index	Pain as measured by the The Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score.	24 weeks
Secondary	Magnetic Resonance Imaging	Changes in the MRI knee with cartilage mapping and clinical improvement assessed by radiologist.	24 weeks
Secondary	KSCRS(Knee Society Clinical rating System)	Changes in exercise score and function of joint evaluation by KSCRS(Knee Society Clinical rating System).	24 weeks
Secondary	VAS(11-point box visual analogue scale)	Changes in VAS(11-point box visual analogue scale) score.	24 weeks
Secondary	Histological evaluates	Biopsy specimens subject to safranin-O staining and immunohistochemistry for type I and II collagen. Thickness of the articular cartilage before and after injection measure, and specimens evaluate with ICRS II by a blind histopathologist.	24 weeks