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OsteoarthritisPhase 2NCT03164083

The Effects of Stromal Vascular Fraction and Mesenchymal Stem Cells as Intra-articular Injection in Knee Joint Osteoarthritis

A Phase 2 study testing Mesenchymal stem cell in people with Osteoarthritis, run by SCARM Institute, Tabriz, Iran at 1 site in Iran.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 65 years
Conditions the study is for
Osteoarthritis
What is being tested?
Mesenchymal stem cell
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteIran
Study dates
10 Nov 2019to 5 Dec 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Osteoarthritis diagnosed by MRI

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Iran1 site

  • SCARM Institute

    Tabriz

Other trials in Iran

About this study

Official title: Evaluation the Effects of Intra-articular Injection of Mesenchymal Stem Cells and Stromal Vascular Fraction Patients With Knee Joint Osteoarthritis, Triple Blind Randomized Clinical Trial

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

Read the detailed description

This is single center, randomized, triple blind phase II clinical study. Patients will be divided into two groups of case and control. All subjects will undergo bone marrow aspiration. Mesenchymal Stem Cells will be isolated from bone marrow and stromal Vascular Fraction fram lipoaspirate, cultured and transplanted back to the knee joint. Patients of case group will receive cell injection 1 and 4 months after bone marrow aspiration. Placebo will be administered in this group 6 months after the first injection. Patients of control group will receive placebo 1 and 4 months after bone marrow aspiration. They all receive cell injection 6 months after first placebo injection. Follow up visit will occur at 2 and 6 weeks, and 3 and 6 months after the first injection. Radiological exams will be performed before and 6 months after the first injection by MRI. Clinical quantitative assessment will measure joint function by the WOMAC index and pain by the visual analogue scale

Conditions
Osteoarthritis
Being tested
Mesenchymal stem cell, Placebo
Keywords
Joint Diseases, Musculoskeletal Diseases, Arthritis
Medical subject headings
Osteoarthritis, Joint Diseases, Musculoskeletal Diseases, Arthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mesenchymal stem cellBiological

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

  • PlaceboBiological

    Patients with knee joint osteoarthritis who underwent intra articular placebo injection

Study groups in NCT03164083
Study groupRoleWhat they receive
mesenchymal stem cellExperimentalPatients with knee joint osteoarthritis who underwent intra articular mesenchymal stem cell injection
Receives: Biological: Mesenchymal stem cell
placeboExperimentalThe patients who are in control group and underwent placebo injection
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. physical function improvement

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

    Measured: 2 weeks

  2. Change in pain density

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

    Measured: 2 weeks

Secondary outcomes (4)

  1. Joint swelling

    Evaluation the joint swelling by physical examination after intra articular cell injection

    Measured: 3 months

  2. Joint erythema

    Evaluation the joint erythema by physical examination after cell injection

    Measured: 3 months

  3. Deterioration of joint function

    Evaluation the deterioration of joint function by physical examination after intra articular cell injection

    Measured: 3 months

  4. Allergic reactions

    Evaluation the allergic reactions like skin rash,skin erythema, dyspnea by physical examination after cell injection

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2017
  2. Study start10 Nov 2019 (estimated)
  3. Primary completion21 Aug 2020 (estimated)
  4. Study completion5 Dec 2020 (estimated)

Why it stopped: not approved by sponsor

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03164083
Sponsor's protocol ID
SCARM-Osteoarthritis-001
Status last verified
Jan 2019
First submitted
21 May 2017
Last updated
18 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28143470

  • 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.

    PubMed 26881220

  • 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.

    PubMed 24326779

  • 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.

    PubMed 22807102

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mesenchymal stem cell in people with Osteoarthritis, run by SCARM Institute, Tabriz, Iran at 1 site in Iran.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

physical function improvement (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03164083, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.

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