NCT03800810

Brief Summary

Prevalence of osteoarthritis increases every year, as a chronic and progressive disease. Osteoarthritis also gives many negative impacts in socio-economic life. Current management of osteoarthritis only aimed to relieve pain but not to resolve the degeneration of cartilage. Mesenchymal stem cell is one kind of adult stem cell that has potency in tissue engineering. Sources of mesenchymal stem cell are bone marrow, adipose tissue and umbilical cord. Researchers want to explore the potential of umbilical cord as the source of allogeneic MSC, because the gaining process of MSC is not invasive. Some countries have started some In vitro studies, Animal studies, and human research, but in Indonesia the study of mesenchymal stem cell implantation from umbilical cord in genu osteoarthritis management has not been reported. This study will be held into two years in Cipto Mangunkusumo Hospital and include 9 participants minimally. The researcher also compares the efficacy and safety of MSC implantation from umbilical cord applied to genu osteoarthritis with synovial artificial and recombinant human growth hormone therapy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
9

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started May 2015

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2015

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 11, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

4 years

First QC Date

July 2, 2018

Last Update Submit

January 21, 2019

Conditions

Osteoarthritis, Knee

Keywords

OsteoarthritisMesenchymal Stem CellsUmbilical Cord

Outcome Measures

Primary Outcomes (4)

  • Cartilage T2 map score

    MRI examination of the knee with additional T2 mapping software CartiGram (GE Healthcare, USA). T2 map sequence are obtained from the medial and lateral aspect of both femoral and tibial cartilage.

    6 months

  • IKDC score

    Subjective assessment of knee function using the International Knee Documentation Committee Subjective Knee Evaluation form. Scale ranges from 1 to 100, higher value indicates higher function.

    3 months

  • WOMAC score

    Subjective assessment of knee function using the the Western Ontario and McMaster Universities Osteoarthritis Index. Scale ranges from 100% to 1%, lower value indicates higher function.

    3 months

  • VAS score

    VAS score is used to assess knee pain experienced by subjects.

    3 months

Study Arms (4)

Control

EXPERIMENTAL

Week 1: Intraarticular injection of 2 ml hyaluronic acid (Synvisc-One® Hylan G-F 20, Sanofi-Aventis) Week 2: Intraarticular injection of 2 ml hyaluronic acid (Synvisc-One® Hylan G-F 20, Sanofi-Aventis) Week 3: Intraarticular injection of 2 ml hyaluronic acid (Synvisc-One® Hylan G-F 20, Sanofi-Aventis)

Drug: Hyaluronic Acid

Intervention 1

EXPERIMENTAL

Week 1: Intraarticular injection of 10x10\^6 unit of umbilical cord mesenchymal stem cells in 2 ml conditioned medium, 2 ml hyaluronic acid (Synvisc-One® Hylan G-F 20, Sanofi-Aventis) Week 2: Intraarticular injection of 2 ml hyaluronic acid (Synvisc-One® Hylan G-F 20, Sanofi-Aventis), 8 IU recombinant human somatropin (Novell-Eutropin®, Novell Pharmaceutical Laboratories) Week 3: Intraarticular injection of 2 ml hyaluronic acid (Synvisc-One® Hylan G-F 20, Sanofi-Aventis), 8 IU recombinant human somatropin (Novell-Eutropin®, Novell Pharmaceutical Laboratories)

Drug: Hyaluronic AcidBiological: Umbilical Cord Mesenchymal Stem CellBiological: Recombinant Human Somatropin

Intervention 2

EXPERIMENTAL

Week 1: Intraarticular injection of 10x10\^6 unit of umbilical cord mesenchymal stem cells in 2 ml conditioned medium, 2 ml hyaluronic acid (Synvisc-One® Hylan G-F 20, Sanofi-Aventis) Week 2: Intraarticular injection of 2 ml hyaluronic acid (Synvisc-One® Hylan G-F 20, Sanofi-Aventis) Week 3: Intraarticular injection of 2 ml hyaluronic acid (Synvisc-One® Hylan G-F 20, Sanofi-Aventis)

Drug: Hyaluronic AcidBiological: Umbilical Cord Mesenchymal Stem Cell

Intervention 3

EXPERIMENTAL

Week 1: Intraarticular injection of 10x10\^6 unit of umbilical cord mesenchymal stem cells in 2 ml conditioned medium, 2 ml hyaluronic acid (Synvisc-One® Hylan G-F 20, Sanofi-Aventis) Week 2: Intraarticular injection of 2 ml hyaluronic acid (Synvisc-One® Hylan G-F 20, Sanofi-Aventis), 8 IU recombinant human somatropin (Novell-Eutropin®, Novell Pharmaceutical Laboratories) Week 3: Intraarticular injection of 2 ml hyaluronic acid (Synvisc-One® Hylan G-F 20, Sanofi-Aventis), 8 IU recombinant human somatropin (Novell-Eutropin®, Novell Pharmaceutical Laboratories)

Drug: Hyaluronic AcidBiological: Recombinant Human Somatropin

Interventions

Hyaluronic AcidDRUG
Also known as: Hyaluronan
ControlIntervention 1Intervention 2Intervention 3
Umbilical Cord Mesenchymal Stem CellBIOLOGICAL
Intervention 1Intervention 2
Recombinant Human SomatropinBIOLOGICAL
Intervention 1Intervention 3

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 30-80 years old
  • Kellgren-Lawrence grade I, II, and III, or KL grade III with corrective osteotomy according to knee x-ray examination
  • Minimal VAS: 2
  • Unresponsive with pharmacological therapy
  • Signed the informed consent

You may not qualify if:

  • Osteoarthritis KL grade IV
  • Secondary osteoarthritis due to trauma, infection, rheumatoid arthritis, congenital diseases, autoimmune diseases
  • Hypersensitivity to hyaluronic acid
  • Malignancies (Previously or currently diagnosed)
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitas Indonesia

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

RECRUITING

Related Publications (10)

  • Solomon L, Warwic DJ, Nagayam S. Osteoarthritis. In : Apple's System if Orthopaedics and Fractures 8th Edition.oxford University Press. New York : 2001. P 77-90

    BACKGROUND

  • Singh A, Goel SC, Gupta KK, Kumar M, Arun GR, Patil H, Kumaraswamy V, Jha S. The role of stem cells in osteoarthritis: An experimental study in rabbits. Bone Joint Res. 2014 Feb 13;3(2):32-7. doi: 10.1302/2046-3758.32.2000187. Print 2014.

    PMID: 24526748BACKGROUND

  • Tsai SY, Huang YC, Chueh LL, Yeh LS, Lin CS. Intra-articular transplantation of porcine adipose-derived stem cells for the treatment of canine osteoarthritis: A pilot study. World J Transplant. 2014 Sep 24;4(3):196-205. doi: 10.5500/wjt.v4.i3.196.

    PMID: 25346893BACKGROUND

  • Kim SB, Kwon DR, Kwak H, Shin YB, Han HJ, Lee JH, Choi SH. Additive effects of intra-articular injection of growth hormone and hyaluronic acid in rabbit model of collagenase-induced osteoarthritis. J Korean Med Sci. 2010 May;25(5):776-80. doi: 10.3346/jkms.2010.25.5.776. Epub 2010 Apr 16.

    PMID: 20436717BACKGROUND

  • Vangsness CT Jr, Farr J 2nd, Boyd J, Dellaero DT, Mills CR, LeRoux-Williams M. Adult human mesenchymal stem cells delivered via intra-articular injection to the knee following partial medial meniscectomy: a randomized, double-blind, controlled study. J Bone Joint Surg Am. 2014 Jan 15;96(2):90-8. doi: 10.2106/JBJS.M.00058.

    PMID: 24430407BACKGROUND

  • Dart AJ, Little CB, Hughes CE, Chu O, Dowling BA, Hodgson DR, Rose RJ, Johnson KA. Recombinant equine growth hormone administration: effects on synovial fluid biomarkers and cartilage metabolism in horses. Equine Vet J. 2003 May;35(3):302-7. doi: 10.2746/042516403776148165.

    PMID: 12755435BACKGROUND

  • White DK, Keysor JJ, Lavalley MP, Lewis CE, Torner JC, Nevitt MC, Felson DT. Clinically important improvement in function is common in people with or at high risk of knee OA: the MOST study. J Rheumatol. 2010 Jun;37(6):1244-51. doi: 10.3899/jrheum.090989. Epub 2010 Apr 15.

    PMID: 20395640BACKGROUND

  • Raynauld JP, Torrance GW, Band PA, Goldsmith CH, Tugwell P, Walker V, Schultz M, Bellamy N; Canadian Knee OA Study Group. A prospective, randomized, pragmatic, health outcomes trial evaluating the incorporation of hylan G-F 20 into the treatment paradigm for patients with knee osteoarthritis (Part 1 of 2): clinical results. Osteoarthritis Cartilage. 2002 Jul;10(7):506-17. doi: 10.1053/joca.2002.0798.

    PMID: 12127830BACKGROUND

  • Higgins LD, Taylor MK, Park D, Ghodadra N, Marchant M, Pietrobon R, Cook C; International Knee Documentation Committee. Reliability and validity of the International Knee Documentation Committee (IKDC) Subjective Knee Form. Joint Bone Spine. 2007 Dec;74(6):594-9. doi: 10.1016/j.jbspin.2007.01.036. Epub 2007 Aug 6.

    PMID: 17888709BACKGROUND

  • Sinusas K. Osteoarthritis: diagnosis and treatment. Am Fam Physician. 2012 Jan 1;85(1):49-56.

    PMID: 22230308BACKGROUND

Related Links

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Interventions

Hyaluronic AcidHuman Growth Hormone

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydratesGrowth HormonePituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Central Study Contacts

Ismail H Dilogo, MD, PhD

CONTACT

+622144539917ismailorthofkui@yahoo.co.id

Tri Kurniawati, BSc

CONTACT

+622144539917selpuncarscm@yahoo.co.id

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant, Department of Orthopaedics and Traumatology

Study Record Dates

First Submitted

July 2, 2018

First Posted

January 11, 2019

Study Start

May 1, 2015

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

January 23, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will share

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Locations

ID(1)