Mesenchymal Stem Cells In Treatment Of Knee Osteoarthritis

The Effect And Safety Of Allogenic Adipose-Derived Mesenchymal Stem Cells In Treatment Of Knee Osteoarthritis, Pilot Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016021123298N3

Enrollment

Registered

2016-02-20

Start date

2016-04-03

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

osteoarthritis. Primary arthrosis NOS

Interventions

Intervention 1: 10 patients in case group will receive 30 million adipose-derided mesenchymal stem cells in a single intraarthicular injection. Intervention 2: 10 patient in the control group will rec

Treatment - Other

Placebo

10 patients in case group will receive 30 million adipose-derided mesenchymal stem cells in a single intraarthicular injection.

10 patient in the control group will receive single intraarthicular injection of PBS (Phosphate Buffered Saline) in a sterile setting.

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: inclusion criteria: knee osteoarthritis based on ACR (American College of Rheumatology) criteria and grade 1,2,3 based on Kellgren-Lawrence grading scale; Ability to follow during the study period exclusion criteria: age 75 years; presence of any acute or chronic infectious process; knee deformity (varus >10 ° or valgus >20° ); impaired renal function(creatinine>2.0 mg/dl); impaired liver function(Bilirubin > 2.0 ?/?, AST/ALT > 100 IU/L); Pregnancy or lactating; neoplasia; BMI>35; Immunosuppressive state; Systemic autoimmune rheumatic disease or secondary osteoarthritis; intraarthicular injections in last 3 months; history of knee surgery; Poorly controlled diabetes mellitus

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
KOOS value. Timepoint: before,2 weeks,2 months and 6 months after injection. Method of measurement: KOOS questionnaire.;VAS value. Timepoint: before,2 weeks,2 months and 6 months after injection. Method of measurement: VAS.;Knee range of motion. Timepoint: before,2 weeks,2 months and 6 months after injection. Method of measurement: goniometer.;Radiologic MRA parameters. Timepoint: before and 6 months after injection. Method of measurement: MRA(magnetic resonance arthrography).	—

Measure

Time frame

KOOS value. Timepoint: before,2 weeks,2 months and 6 months after injection. Method of measurement: KOOS questionnaire.;VAS value. Timepoint: before,2 weeks,2 months and 6 months after injection. Method of measurement: VAS.;Knee range of motion. Timepoint: before,2 weeks,2 months and 6 months after injection. Method of measurement: goniometer.;Radiologic MRA parameters. Timepoint: before and 6 months after injection. Method of measurement: MRA(magnetic resonance arthrography).

—

Secondary

Measure	Time frame
Clinical sign and symptoms of inflammatory and allergic reactions. Timepoint: before,30 minute,2 weeks,2 months and 6 month after injection. Method of measurement: physical examination(swelling, erythema, skin rash, fever, effusion).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDoctor Shayesteh Sadat Khalifesoltani

Iran University of Medical Science

shayesteh_khalifesoltani@yahoo.com+98 21 86701

Outcome results

None listed

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