ClinicalTrials.gg
WithdrawnNCT03164083Updated Mar 18, 2020

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

A Phase 2 interventional study of Mesenchymal stem cell and Placebo in Osteoarthritis, sponsored by SCARM Institute, Tabriz, Iran. Withdrawn at 1 site in Iran, Islamic Republic of. Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-03-18.

Sponsored by SCARM Institute, Tabriz, Iran · Phase 2, Interventional, and Treatment

Why this study was withdrawn
not approved by sponsor
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 13 studies in Osteoarthritis with a site in Iran, Islamic Republic of — 1 open to participants now, 1 under way, none of them phase 3. Osteoarthritis · Iran, Islamic Republic of.

Enrollment
13th of 13
0 · median 40
Started
2019
with 1 other
Phase 2
4 of 13
none open now
Registered
10th of 13
by date
Lead sponsor
1 of 13
SCARM Institute, Tabriz, Iran

Among the 13 studies in Osteoarthritis with a site in Iran, Islamic Republic of, this one is the 13th largest by enrollment, is one of 2 that started in 2019, is one of 4 in phase 2, and was the 10th registered.

Osteoarthritis

2,974 studies on the registry are indexed under Osteoarthritis; 437 are open to participants now.

Browse Osteoarthritis studies →

Open to participants now

1 of the 13 studies in Osteoarthritis with a site in Iran, Islamic Republic of is open now. Recruiting first, the newest first:

A study can be open while its sites in Iran, Islamic Republic of have not opened yet or have stopped. Only those recruiting at a site in Iran, Islamic Republic of →

Who these studies take

Of the 286 Osteoarthritis studies recruiting now, 158 (55%) set no upper age limit and 71 (25%) stop at 75 or younger; 22 take children under 18; 30 take healthy volunteers.

This study: 25 Years to 65 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 13 studies in Osteoarthritis with a site in Iran, Islamic Republic of, or all of them as a file.
02

Study 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

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

03

Conditions studied

  • Osteoarthritis

Keywords

  • Joint Diseases
  • Musculoskeletal Diseases
  • Arthritis
04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Osteoarthritis diagnosed by MRI

Exclusion criteria

Exclusion Criteria:

  • Pregnancy or lactating
  • Positive tests for , virus (HCV), Hepatitis C virus ()
  • Active neurologic disorder
  • End organ damage
  • Uncontrolled endocrine disorder
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    mesenchymal stem cell

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

    Biological: Mesenchymal stem cell

  • Experimental
    placebo

    The patients who are in control group and underwent placebo injection

    Biological: Placebo

Interventions

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

  • BiologicalPlacebo

    Patients with knee joint osteoarthritis who underwent intra articular placebo injection

06

What researchers measure

Primary outcomes

  1. physical function improvement

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

    Time frame: 2 weeks

  2. Change in pain density

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

    Time frame: 2 weeks

Secondary outcomes

  1. Joint swelling

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

    Time frame: 3 months

  2. Joint erythema

    Evaluation the joint erythema by physical examination after cell injection

    Time frame: 3 months

  3. Deterioration of joint function

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

    Time frame: 3 months

  4. Allergic reactions

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

    Time frame: 3 months

07

Study locations

1 site
  • SCARM Institute
    Tabriz, Iran, Islamic Republic of
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2019; primary completion for Aug 2020, 9 months later.

How these figures are worked out, and which studies are left out of them.

Registered
May 21, 2017
First posted
May 23, 2017
StartEst.
Nov 10, 2019
Primary completionEst.
Aug 21, 2020
CompletionEst.
Dec 5, 2020
Last update
Mar 18, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03164083
Lead sponsor
SCARM Institute, Tabriz, Iran
Responsible party
Sponsor
First posted
May 23, 2017
Start date
Nov 10, 2019 (estimated)
Primary completion
Aug 21, 2020 (estimated)
Completion
Dec 5, 2020 (estimated)
Last update
Mar 18, 2020

Study contacts

Mohammad Nouri, Ph.D
study chair · Head of SCARM Institute
Peyman Keyhanvar, MD, Ph.D
study director · Deputy for translational medicine of SCARM institute
Seyed Kazem Shakouri, Physiatrist
principal investigator · Tabriz University of Medical Sciences
Neda keyhanvar, Ph.D
principal investigator · SCARM institute
Sepideh Bastani, MSc
principal investigator · SCARM institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: Mesenchymal Stem Cell

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