Dose-escalation of Cellistem-OA in Patients With Knee Osteoarthritis (CLT-OA1)

January 17, 2019 updated by: Francisco Espinoza, Universidad de los Andes, Chile

A Phase I Dose-escalation Trial to Assess Safety and Efficacy of Cellistem-OA in Patients With Knee Osteoarthritis (CLT-OA1)

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Xiii
      • Santiago, Xiii, Chile, 7620001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CLT low-dose
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
Intra-articular infiltration of umbilical cord derived-mesenchymal stromal cells
Experimental: CLT medium-dose
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
Intra-articular infiltration of umbilical cord derived-mesenchymal stromal cells
Experimental: CLT high-dose
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
Intra-articular infiltration of umbilical cord derived-mesenchymal stromal cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in WOMAC score
Time Frame: 6 months
6 months
Change in VAS score
Time Frame: 6 months
6 months
Changes in structural joint assessment by MRI
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de los Andes, Chile

Investigators

  • Principal Investigator: Francisco Espinoza, MD, CMO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2019

Primary Completion (Anticipated)

October 30, 2019

Study Completion (Anticipated)

December 30, 2019

Study Registration Dates

First Submitted

January 17, 2019

First Submitted That Met QC Criteria

January 17, 2019

First Posted (Actual)

January 18, 2019

Study Record Updates

Last Update Posted (Actual)

January 18, 2019

Last Update Submitted That Met QC Criteria

January 17, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLT-OA1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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