NCT03164083

Brief Summary

Osteoarthritis of the knee is one of the most common causes of disability among elderly. As the disease progresses the cartilage become frustrated, surrounding bone react to become thicker and inflammation occurs in subchondral bone seen in T2-weighted MRI as increase in signal density. Patients are treated initially by pain management. In patients who don't response to first line treatment invasive treatment like total knee replacement is done. The investigators designed this clinical study with the aim of evaluating therapeutic effects of intra-articular injection of bone marrow Mesenchymal Stem Cells (MSC) and stromal Vascular Fraction (SVF) in patients with severe knee osteoarthritis

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

May 21, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2017

Completed
2.5 years until next milestone

Study Start

First participant enrolled

November 10, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2020

Completed
Last Updated

March 18, 2020

Status Verified

January 1, 2019

Enrollment Period

10 months

First QC Date

May 21, 2017

Last Update Submit

March 16, 2020

Conditions

Osteoarthritis

Keywords

Joint DiseasesMusculoskeletal DiseasesArthritis

Outcome Measures

Primary Outcomes (2)

  • physical function improvement

    Evaluation the physical function improvement Measured by WOMAC osteoarthritis index after cell injection

    2 weeks

  • Change in pain density

    Evaluation the changing of pain density measured by Visual Analogue Scale after cell injection

    2 weeks

Secondary Outcomes (4)

  • Joint swelling

    3 months

  • Joint erythema

    3 months

  • Deterioration of joint function

    3 months

  • Allergic reactions

    3 months

Study Arms (2)

mesenchymal stem cell

EXPERIMENTAL

Patients with knee joint osteoarthritis who underwent intra articular mesenchymal stem cell injection

Biological: Mesenchymal stem cell

placebo

EXPERIMENTAL

The patients who are in control group and underwent placebo injection

Biological: Placebo

Interventions

Mesenchymal stem cellBIOLOGICAL

intra articular injection of mesenchymal stem cell Other Name: stem cell transplantation

mesenchymal stem cell
PlaceboBIOLOGICAL

Patients with knee joint osteoarthritis who underwent intra articular placebo injection

placebo

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Osteoarthritis diagnosed by MRI

You may not qualify if:

  • Pregnancy or lactating
  • Positive tests for HIV, Hepatitis C virus (HCV), Hepatitis C virus (HBV)
  • Active neurologic disorder
  • End organ damage
  • Uncontrolled endocrine disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SCARM Institute

Tabriz, Iran

Location

Related Publications (4)

  • Pak J, Lee JH, Park KS, Park M, Kang LW, Lee SH. Current use of autologous adipose tissue-derived stromal vascular fraction cells for orthopedic applications. J Biomed Sci. 2017 Jan 31;24(1):9. doi: 10.1186/s12929-017-0318-z.

    PMID: 28143470RESULT

  • Pak J, Lee JH, Kartolo WA, Lee SH. Cartilage Regeneration in Human with Adipose Tissue-Derived Stem Cells: Current Status in Clinical Implications. Biomed Res Int. 2016;2016:4702674. doi: 10.1155/2016/4702674. Epub 2016 Jan 6.

    PMID: 26881220RESULT

  • Koh YG, Choi YJ, Kwon SK, Kim YS, Yeo JE. Clinical results and second-look arthroscopic findings after treatment with adipose-derived stem cells for knee osteoarthritis. Knee Surg Sports Traumatol Arthrosc. 2015 May;23(5):1308-1316. doi: 10.1007/s00167-013-2807-2. Epub 2013 Dec 11.

    PMID: 24326779RESULT

  • Pires de Carvalho P, Hamel KM, Duarte R, King AG, Haque M, Dietrich MA, Wu X, Shah F, Burk D, Reis RL, Rood J, Zhang P, Lopez M, Gimble JM, Dasa V. Comparison of infrapatellar and subcutaneous adipose tissue stromal vascular fraction and stromal/stem cells in osteoarthritic subjects. J Tissue Eng Regen Med. 2014 Oct;8(10):757-62. doi: 10.1002/term.1565. Epub 2012 Jul 16.

    PMID: 22807102RESULT

MeSH Terms

Conditions

OsteoarthritisJoint DiseasesMusculoskeletal DiseasesArthritis

Condition Hierarchy (Ancestors)

Rheumatic Diseases

Study Officials

  • Mohammad Nouri, Ph.D

    Head of SCARM Institute

    STUDY CHAIR

  • Peyman Keyhanvar, MD, Ph.D

    Deputy for translational medicine of SCARM institute

    STUDY DIRECTOR

  • Seyed Kazem Shakouri, Physiatrist

    Tabriz University of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Neda keyhanvar, Ph.D

    SCARM institute

    PRINCIPAL INVESTIGATOR

  • Sepideh Bastani, MSc

    SCARM institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2017

First Posted

May 23, 2017

Study Start

November 10, 2019

Primary Completion

August 21, 2020

Study Completion

December 5, 2020

Last Updated

March 18, 2020

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)