Clinical trial NCT03164083: The Effects of Stromal Vascular Fraction and Mesenchymal Stem Cells as Intra-articular Injection in Knee Joint Osteoarthritis
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Osteoarthritis
Keywords: Joint Diseases
Musculoskeletal Diseases
Arthritis
Lead sponsor: SCARM Institute, Tabriz, Iran
Sponsor class: OTHER_GOV
First posted: 2017-05-23
Enrollment: 0
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility criteria: Inclusion Criteria:

* Osteoarthritis diagnosed by MRI

Exclusion Criteria:

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

Primary outcomes:
measure: physical function improvement
timeFrame: 2 weeks
measure: Change in pain density
timeFrame: 2 weeks
Secondary outcomes:
measure: Joint swelling
timeFrame: 3 months
measure: Joint erythema
timeFrame: 3 months
measure: Deterioration of joint function
timeFrame: 3 months
measure: Allergic reactions
timeFrame: 3 months
Other outcomes:
Locations:
city: Tabriz
country: Iran, Islamic Republic of
facility: SCARM Institute
Study officials:
affiliation: Head of SCARM Institute
name: Mohammad Nouri, Ph.D
role: STUDY_CHAIR
affiliation: Deputy for translational medicine of SCARM institute
name: Peyman Keyhanvar, MD, Ph.D
role: STUDY_DIRECTOR
affiliation: Tabriz University of Medical Sciences
name: Seyed Kazem Shakouri, Physiatrist
role: PRINCIPAL_INVESTIGATOR
affiliation: SCARM institute
name: Neda keyhanvar, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: SCARM institute
name: Sepideh Bastani, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.