NCT01300598

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2008

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 21, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

June 5, 2019

Status Verified

June 1, 2019

Enrollment Period

2.8 years

First QC Date

February 17, 2011

Last Update Submit

June 3, 2019

Conditions

Degenerative Arthritis

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Magnetic Resonance Imaging

    24 weeks

  • KSCRS(Knee Society Clinical rating System)

    24 weeks

  • VAS(11-point box visual analogue scale)

    24 weeks

  • Histological evaluates

    24 weeks

Other Outcomes (3)

  • cartilage volume of the knee joint

    24 weeks

  • Arthroscopy

    24 weeks

  • X-ray

    24 weeks

Interventions

Autologous Adipose Tissue derived MSCs TransplantationPROCEDURE

Intra-articular infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 1x10e7 cells/3mL,5x10e7 cells/3mL, 1x10e8 cells/3mL

Also known as: RNL-JointStem®

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Women who are pregnant or breast feeding or planning to become pregnant during 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).
  • Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SMG-SNU Boramae Hospital

Seoul, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 24449146RESULT

  • 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.

    PMID: 28746812RESULT

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Kang Sup Yoon, M.D. & Ph.D.

    SMG-SNU Boramae Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2011

First Posted

February 21, 2011

Study Start

December 1, 2008

Primary Completion

September 1, 2011

Study Completion

March 1, 2012

Last Updated

June 5, 2019

Record last verified: 2019-06

Locations

KR(1)