Mesenchymal Stem Cells In Treatment Of Knee Osteoarthritis

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015101823298N2

Enrollment

Registered

2016-03-16

Start date

2015-11-22

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 50 million placental mesenchymal stem cells in a single intraarthicular injection. Intervention 2: 10 patient in the control group will receive s

Treatment - Other

Placebo

10 patients in case group will receive 50 million placental 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 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 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 82141229

Outcome results

None listed

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