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Adipose-derived Mesenchymal Stem Cells in Osteoarthritis

NCT03869229 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-04-09

No results posted yet for this study

Summary

This phase I/II study will enroll 100 subjects with mild to moderate osteoarthritis of the hip/knee/glenohumeral joints will be enrolled according to strict inclusion and exclusion criteria. Subjects will receive a single dose of at least 10 million of autologous Adipose-derived Mesenchymal Stem Cells (ADMCS) every three months for 12 months (maximum four doses in total and at least 40 million of ADMCS in total) via ultrasound guided intra-articular injection.

Conditions

Interventions

BIOLOGICAL

Intra-articular injection of ADMSC

Intervention: Intra-articular injection of Adipose-derived Mesenchymal Stem Cells (ADMSC)- ultrasound guided intra-articular injection of at least 10 million of ADMCS per procedure, maximum four procedures (i.e. injections per joint), minimum number of cells pre protocol 40 million

Sponsors & Collaborators

  • Medical University of Warsaw

    lead OTHER

Principal Investigators

  • Marek Postula, MD, PhD · Medical University of Warsaw

  • Robert Smiegielski, MD · Life Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-05
Primary Completion
2020-03-01
Completion
2022-03-20

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

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 NCT03869229 on ClinicalTrials.gov