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

NCT05751564 | Unknown Phase 2 DMC

• 1 other identifier: PANLAR-II
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Osteoarthritis; Degenerative joint disease; Cell therapy; Advanced Medicinal Therapy Product; Mesenchymal Stromal Cell; Mesenchymal Stem Cell; Cryopreserved cell therapy

Outcome Measures

Primary Outcomes (1)

• Safety monitoring for Adverse events

  Adverse events (AEs) reported for each study group as coded by the Common Terminology Criteria for Adverse Event classification.

  12 months

Secondary Outcomes (4)

• WOMAC scale

  12 months

• Pain Visual Analog Scale (VAS)

  12 months

• Quality of Life SF-36 questionnaire

  12 months

• Responder status

  12 months

Other Outcomes (1)

• WORMS SCORE

  12 months

Study Arms (2)

"Ready to inject" MSC product

EXPERIMENTAL

Cryopreserved "ready to inject" Umbilical Cord (UC) derived MSC

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

Resuspended MSC product

ACTIVE COMPARATOR

Umbilical Cord (UC) derived MSC in suspension media

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

Interventions

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

Cryopreserved thaw \& inject MSC intra-articular therapy

Also known as: Cryopreserved "Ready to inject" MSC product

"Ready to inject" MSC product

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

Cryopreserved resuspended MSC intra-articular therapy

Also known as: Cryopreserved resuspended MSC product

Resuspended MSC product

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic knee OA defined by grade 1-3 Kellgren-Lawrence radiographic changes in the targeted knee.

You may not qualify if:

• Bilateral symptomatic knee OA (only if the contralateral knee has more severe disease)
• Meniscal rupture.
• Condylar or tibial plateau generalized bone marrow edema on MRI
• Major axial deviation defined by valgus (\>10°) or varus (5°) deformity of the involved leg
• Use of oral or intra-articular steroids or hyaluronic acid in the past 6 months
• Ipsilateral hip or ankle pain, local or systemic infection
• Any form of secondary arthritis, previous malignancy, or body mass index ≥30.

Sponsors & Collaborators

• Universidad de los Andes, Chile: lead
• Liga Panamericana de Asociaciones de Reumatologia (PANLAR): collaborator

Related Publications (1)

• Matas J, Orrego M, Amenabar D, Infante C, Tapia-Limonchi R, Cadiz MI, Alcayaga-Miranda F, Gonzalez PL, Muse E, Khoury M, Figueroa FE, Espinoza F. Umbilical Cord-Derived Mesenchymal Stromal Cells (MSCs) for Knee Osteoarthritis: Repeated MSC Dosing Is Superior to a Single MSC Dose and to Hyaluronic Acid in a Controlled Randomized Phase I/II Trial. Stem Cells Transl Med. 2019 Mar;8(3):215-224. doi: 10.1002/sctm.18-0053. Epub 2018 Dec 28.

  PMID: 30592390 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis; Joint Diseases

Interventions

Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Arthritis; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Fernando E Figueroa, M.D.

  Universidad de Los Andes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernando E Fernando, M.D.

CONTACT

+56 953722433; ffigueroa@uandes.cl

Francisco Espinoza, M.D.

CONTACT

+56 942201289; fespinoza@clinicauandes.cl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, providers, investigators and outcome assessments will be blind to randomization except in need to open code for security reasons
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective Double blind Randomized Controlled Trial

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: March 2, 2023
• Study Start: April 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: April 1, 2025
• Last Updated: March 2, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: At trial termination and publication.
• Access Criteria: Data will be shared with researchers or scholars with no conflict of interest and once we have confirmed the data are not subject to confidentiality due to intellectual property or other issues.