Allogeneic stem cell transplantation in knee joint osteoarthritis

Evaluation of safety and efficacy of intra-articular transplantation of allogeneic adipose derived mesenchymal stromal cells in patients with knee joint osteoarthritis An interventional randomized triple-blind placebo controlled clinical trial phase I/II

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20080728001031N23

Enrollment

100

Registered

2018-04-24

Start date

2017-03-14

Completion date

Unknown

Last updated

2021-08-30

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

Conditions

cell therapy in osteoarthritis. Polyosteoarthritis, unspecified

Interventions

Intervention 1: Phase I and case group in phase II: intraarticular transplantation of single dose 100 millions of allogeneic adipose derived mesenchymal stem cells. Intervention 2: Control group (phas

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShahedeh Karimi Torshizi

Royan cell therapy center

karimi58shah@gmail.com+98 21 2356 2000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 11, 2026