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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mesenchymal stem cell | Experimental | Patients with knee joint osteoarthritis who underwent intra articular mesenchymal stem cell injection |
|
| placebo | Experimental | The patients who are in control group and underwent placebo injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenchymal stem cell | Biological | intra articular injection of mesenchymal stem cell Other Name: stem cell transplantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Joint swelling | Evaluation the joint swelling by physical examination after intra articular cell injection | 3 months |
| Joint erythema | Evaluation the joint erythema by physical examination after cell injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SCARM Institute | Tabriz | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28143470 | Result | 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. | |
| 26881220 | Result | 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. |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D012216 | Rheumatic Diseases |
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| Placebo | Biological | Patients with knee joint osteoarthritis who underwent intra articular placebo injection |
|
| 3 months |
| Deterioration of joint function | Evaluation the deterioration of joint function by physical examination after intra articular cell injection | 3 months |
| Allergic reactions | Evaluation the allergic reactions like skin rash,skin erythema, dyspnea by physical examination after cell injection | 3 months |
| 24326779 | Result | 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. |
| 22807102 | Result | 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. |