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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03164083
• Other study ID #: SCARM-Osteoarthritis-001
• Status: Withdrawn
• Phase: Phase 2
• Start date: November 10, 2019
• Est. completion date: December 5, 2020

Study information

• Verified date: January 2019
• Source: SCARM Institute, Tabriz, Iran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 5, 2020
• Est. primary completion date: August 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Biological:
• Mesenchymal stem cell
intra articular injection of mesenchymal stem cell Other Name: stem cell transplantation
• Placebo
Patients with knee joint osteoarthritis who underwent intra articular placebo injection

Locations

Country	Name	City	State
Iran, Islamic Republic of	SCARM Institute	Tabriz

Sponsors (1)

Lead Sponsor	Collaborator
SCARM Institute, Tabriz, Iran

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (4)

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):1308-16. doi: 10.1007/s00167-013- — View 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. Review. — View 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. Review. — View 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 cell — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	physical function improvement	Evaluation the physical function improvement Measured by WOMAC osteoarthritis index after cell injection	2 weeks
Primary	Change in pain density	Evaluation the changing of pain density measured by Visual Analogue Scale after cell injection	2 weeks
Secondary	Joint swelling	Evaluation the joint swelling by physical examination after intra articular cell injection	3 months
Secondary	Joint erythema	Evaluation the joint erythema by physical examination after cell injection	3 months
Secondary	Deterioration of joint function	Evaluation the deterioration of joint function by physical examination after intra articular cell injection	3 months
Secondary	Allergic reactions	Evaluation the allergic reactions like skin rash,skin erythema, dyspnea by physical examination after cell injection	3 months