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Adipose-tissue-derived Total-Stromal-cells (TOST) Therapy in Knee Osteoarthritis

NCT05280002 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-03-15

No results posted yet for this study

Summary

In this phase II Randomized Clinical Trial (RCT), impacts of a single Intra-articular injection of autologous adipose tissue derive total-stromal-cells (TOST) on knee pain, physical function, stiffness, and cartilage thickness assessed and compared changes before and after intervention.

Individuals with knee osteoarthritis (KOA) diagnosed by using the American College of Rheumatology (ACR) criteria for Osteoarthritis knee were included in the study. Kellgren-Lawrence (KL) radiological scores were used to define radiological changes and high-frequency musculoskeletal ultrasonogram (MSUS) was used to measure cartilage thickness.

Conditions

  • Osteoarthritis Knees

Interventions

BIOLOGICAL

Adipose Tissue derived Total-Stromal-Cells (TOST)

Single dose autologous aAdipose Tissue derived Total-Stromal-Cells (TOST) containing mesenchymal stem cell was injected in each knee of the participants having knee osteoarthritis.

Sponsors & Collaborators

  • Dhaka Medical College

    collaborator OTHER

  • Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    lead OTHER

Principal Investigators

  • Moshiur Rahman Khasru, MBBS, FCPS · Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2021-10-31
Completion
2021-12-31

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05280002 on ClinicalTrials.gov