Evaluation of Effectiveness of Intra-Articular Injection of Stem Cells on Knee Arthrosis

Evaluation of Effectiveness of Intra-Articular Injection of Bone Marrow Derived Stem Cells for Treatment of Degenerative Knee Osteoarthritis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016021710507N4

Enrollment

Registered

2016-02-20

Start date

2015-09-23

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis. Primary gonarthrosis, bilateral

Interventions

Intervention 1: Intra-articular injection of 2 mL hyaluronan (scaffold) + 2 mL autologus bone-marrow derived mesenchymal stem cell (2-3 million) + 0.2 mL dexamethasone. Intervention 2: Intra-articular

Treatment - Drugs

Placebo

Intra-articular injection of 2 mL hyaluronan (scaffold) + 2 mL autologus bone-marrow derived mesenchymal stem cell (2-3 million) + 0.2 mL dexamethasone

Intra-articular injection of 2 mL hyaluronan + 0.2 mL dexamethasone

Eligibility

Sex/Gender

All

Age

45 Years to 75 Years

Inclusion criteria

Inclusion criteria: INCLUSION CRITERIA: Female or male patient with knee osteoarthritis based on the ACR criteria and knee radiography; Grade 2 or 3 osteoarthritis according to Kellgren and Lawrence grading scale; 45 < Patient’s Age< 75; Signed informed consent; No consumption of glucocorticoids, anti-inflammatory and immunomodulatory medications one week prior to the treatment; No history of previous participating in clinical trials on treatment of osteoarthritis; No intra-articular injection of hyaluronic acid in the past 6 months EXCLUSION CRITERIA: Secondary osteoarthritis; Concurrent connective tissue disorder; Active neurological disease; Severe cardiac disease; Debilitating respiratory disease requiring constant treatment; Any endocrinopathy; Malignancies; Current infectious disease; Psychologic diseases (especially major depression) requiring treatment with antidepressants or related medications; Being under treatment with immunosuppressive or cytotoxic medications; Being under constant treatment with antithrombotic medications; History of allergy to biologic products; Hb < 11 g/dL; Plt < 120*103/µL

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Morphological characteristics of of articular cartilage. Timepoint: Before intervention, 6 months post-intervention, 12 months post-intervention. Method of measurement: Modified version of "Magnetic Resonance Observation of Cartilage Repair Tissue" (Modified MOCART).;Pain. Timepoint: Before intervention, 1 month post-intervention, 3 months post-intervention, 6 months post-intervention, 12 months post-intervention. Method of measurement: Pain Numerical Scale Rating.;Symptoms and function of the affected knee. Timepoint: Before intervention, 1 month post-intervention, 3 months post-intervention, 6 months post-intervention, 12 months post-intervention. Method of measurement: Knee injury and Osteoarthritis Outcome Score (KOOS).;Range of motion. Timepoint: Before intervention, 1 month post-intervention, 3 months post-intervention, 6 months post-intervention, 12 months post-intervention. Method of measurement: Angle with protractor.;Range of motion. Timepoint: Before intervention, 1 month post-intervention, 3 months post-intervention, 6 months post-intervention, 12 months post-intervention. Method of measurement: Angle with protractor.	—

Measure

Time frame

Morphological characteristics of of articular cartilage. Timepoint: Before intervention, 6 months post-intervention, 12 months post-intervention. Method of measurement: Modified version of "Magnetic Resonance Observation of Cartilage Repair Tissue" (Modified MOCART).;Pain. Timepoint: Before intervention, 1 month post-intervention, 3 months post-intervention, 6 months post-intervention, 12 months post-intervention. Method of measurement: Pain Numerical Scale Rating.;Symptoms and function of the affected knee. Timepoint: Before intervention, 1 month post-intervention, 3 months post-intervention, 6 months post-intervention, 12 months post-intervention. Method of measurement: Knee injury and Osteoarthritis Outcome Score (KOOS).;Range of motion. Timepoint: Before intervention, 1 month post-intervention, 3 months post-intervention, 6 months post-intervention, 12 months post-intervention. Method of measurement: Angle with protractor.;Range of motion. Timepoint: Before intervention, 1 month post-intervention, 3 months post-intervention, 6 months post-intervention, 12 months post-intervention. Method of measurement: Angle with protractor.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Ali Ghasemi

Headquarter of Research and Application of Stem Cells

GhasemiAL@mums.ac.ir+98 51 3222 1525

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026