NCT03810521

Brief Summary

A phase I dose-escalation trial to assess safety and efficacy of allogeneic MSC based-treatment (cellistem-OA) in patients with symptomatic knee osteoarthritis

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 18, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

January 18, 2019

Status Verified

January 1, 2019

Enrollment Period

8 months

First QC Date

January 17, 2019

Last Update Submit

January 17, 2019

Conditions

Osteoarthritis, Knee

Keywords

mesenchymal stromal cells

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events

    6 months

Secondary Outcomes (3)

  • Change in WOMAC score

    6 months

  • Change in VAS score

    6 months

  • Changes in structural joint assessment by MRI

    6 months

Study Arms (3)

CLT low-dose

EXPERIMENTAL

Umbilical cord derived-mesenchymal stromal cells at a dose of 2x10e6 cells / 3mL injected by an intra-articular infiltration of affected knee

Biological: umbilical cord derived-mesenchymal stromal cells

CLT medium-dose

EXPERIMENTAL

Umbilical cord derived-mesenchymal stromal cells at a dose of 20x10e6 cells / 3mL injected by an intra-articular infiltration of affected knee

Biological: umbilical cord derived-mesenchymal stromal cells

CLT high-dose

EXPERIMENTAL

Umbilical cord derived-mesenchymal stromal cells at a dose of 80x10e6 cells / 3mL injected by an intra-articular infiltration of affected knee

Biological: umbilical cord derived-mesenchymal stromal cells

Interventions

umbilical cord derived-mesenchymal stromal cellsBIOLOGICAL

Intra-articular infiltration of umbilical cord derived-mesenchymal stromal cells

CLT high-doseCLT low-doseCLT medium-dose

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient between 30 and 75 years old
  • Knee-OA Kellgren Lawrence grade I to III
  • Pain density according to visual analogue scale superior or equal to 50 mm
  • Patelar condromalacia grade I to III
  • Stable joint with normal physical exploration

You may not qualify if:

  • Bilateral symptomatic disease
  • Local or systemic infection
  • Neoplasia
  • Immunosuppression state
  • Pregnancy
  • Anticoagulant therapy
  • Other types of arthritis
  • Symptomatic disease of hip and/or spine
  • Intra-articular infiltration with steroids in the last 3 months
  • Intra-articular infiltration with hyaluronic acid in the last 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ClĂ­nica Universidad de los Andes

Santiago, XIII, 7620001, Chile

RECRUITING

Related Publications (1)

  • Matas J, Garcia C, Poblete D, Vernal R, Ortloff A, Luque-Campos N, Hidalgo Y, Cuenca J, Infante C, Cadiz MI, Khoury M, Luz-Crawford P, Espinoza F. A Phase I Dose-Escalation Clinical Trial to Assess the Safety and Efficacy of Umbilical Cord-Derived Mesenchymal Stromal Cells in Knee Osteoarthritis. Stem Cells Transl Med. 2024 Mar 15;13(3):193-203. doi: 10.1093/stcltm/szad088.

    PMID: 38366909DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Francisco Espinoza, MD

    CMO

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Francisco Espinoza, MD

CONTACT

56226181008fespinoza@uandes.cl

Roberto Bobadilla

CONTACT

56226181000rbobadilla@c4c.cl

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 17, 2019

First Posted

January 18, 2019

Study Start

March 1, 2019

Primary Completion

October 30, 2019

Study Completion

December 30, 2019

Last Updated

January 18, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

CL(1)