Allogeneic stem cell transplantation in knee joint osteoarthritis

Phase 1

• Conditions: cell therapy in osteoarthritis.; Polyosteoarthritis, unspecified; M15.9

• Registration Number: IRCT20080728001031N23
• Lead Sponsor: Royan Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Patients in the range of 18 to 65 years old
osteoarthritis diagnosed by MRI

Exclusion Criteria

Pregnancy or lactating
Positive tests for HIV, HCV, HBV
Active central or peripheral neurologic disorder
End organ damage or Uncontrolled endocrine disorder
Active respiratory disorder and reaction to sedative drugs
history of cancer

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Side effects. Timepoint: One week, one month, 3, 6 and 12 months after transplantation. Method of measurement: Physical examination, adverse effect questionnaire.;Joint function. Timepoint: Before, 3, 6 and 12 months after transplantation. Method of measurement: WOMAC and KOOS questionnaires for osteoarthritis.

Secondary Outcome Measures

Name	Time	Method
Cartilage thickness. Timepoint: Before and 12 months after transplantation. Method of measurement: MRI.;Molecular and cellular indexes (IL-6, IL-10, TNF-a, IFN-?, COMP, CTX-II, HA, CS846, CD4, CD3, CD8, CD25). Timepoint: Before, one week, 3 and 6 months after transplantation. Method of measurement: Blood test.;Subchondral edema. Timepoint: Before and 12 months after transplantation. Method of measurement: MRI.;Joint effusion. Timepoint: Before and 12 months after transplantation. Method of measurement: MRI.;New cartilage formation. Timepoint: Before and 12 months after transplantation. Method of measurement: MRI.