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

Primary Purpose

Osteoarthritis, Knee

Status

Unknown status

Phase

Phase 1

Locations

Chile

Study Type

Interventional

Intervention

umbilical cord derived-mesenchymal stromal cells

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring mesenchymal stromal cells

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Clínica Universidad de los AndesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

CLT low-dose

CLT medium-dose

CLT high-dose

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Incidence of adverse events

Secondary Outcome Measures

Change in WOMAC score

Change in VAS score

Changes in structural joint assessment by MRI

Full Information

NCT ID

NCT03810521

First Posted

January 17, 2019

Last Updated

January 17, 2019

Sponsor

Universidad de los Andes, Chile

1. Study Identification

Unique Protocol Identification Number

NCT03810521

Brief Title

Dose-escalation of Cellistem-OA in Patients With Knee Osteoarthritis

Acronym

CLT-OA1

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

March 1, 2019 (Anticipated)

Primary Completion Date

October 30, 2019 (Anticipated)

Study Completion Date

December 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidad de los Andes, Chile

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee

Keywords

mesenchymal stromal cells

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CLT low-dose

Arm Type

Experimental

Arm Description

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

Arm Title

CLT medium-dose

Arm Type

Experimental

Arm Description

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

Arm Title

CLT high-dose

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

umbilical cord derived-mesenchymal stromal cells

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of adverse events

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Change in WOMAC score

Time Frame

6 months

Title

Change in VAS score

Time Frame

6 months

Title

Changes in structural joint assessment by MRI

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Francisco Espinoza, MD

Phone

56226181008

fespinoza@uandes.cl

First Name & Middle Initial & Last Name or Official Title & Degree

Roberto Bobadilla

Phone

56226181000

rbobadilla@c4c.cl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Francisco Espinoza, MD

Organizational Affiliation

CMO

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clínica Universidad de los Andes

City

Santiago

State/Province

Xiii

ZIP/Postal Code

7620001

Country

Chile

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jose Matas, MD

Phone

56226181000

jmatas@uandes.cl

First Name & Middle Initial & Last Name & Degree

Eduardo Carrasco, MD

Phone

56226181000

ecarrasco@clinicauandes.cl

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Dose-escalation of Cellistem-OA in Patients With Knee Osteoarthritis

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