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"Ready-to-use" Intra-articular Formulation of Mesenchymal Stromal Cells

NCT05751564 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-03-02

No results posted yet for this study

Summary

The goal of this clinical trial is to compare a newly developed off-the-shelf cryopreserved "ready to inject" Mesenchymal Stem Cell (MSC) product with the usual MSC preparation the investigators have used in knee osteoarthritis (OA) patients. Since usual MSC therapy requires cell manipulation in GMP (Good Manufacturing Practices)-type facilities, this new formulation would enable wider access to Cell therapy and Multicentric clinical trials in areas devoid of expensive facilities and equipment.

Conditions

  • Osteo Arthritis Knee

Interventions

BIOLOGICAL

"Ready to inject" Umbilical cord-derived Mesenchymal Stromal Cell (MSC) product

Cryopreserved thaw \& inject MSC intra-articular therapy

BIOLOGICAL

Resuspended Umbilical cord-derived Mesenchymal Stromal Cell (MSC) product

Cryopreserved resuspended MSC intra-articular therapy

Sponsors & Collaborators

  • Liga Panamericana de Asociaciones de Reumatologia (PANLAR)

    collaborator OTHER

  • Universidad de los Andes, Chile

    lead OTHER

Principal Investigators

  • Fernando E Figueroa, M.D. · Universidad de Los Andes

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-04-30
Primary Completion
2024-12-31
Completion
2025-04-30

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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 NCT05751564 on ClinicalTrials.gov