Cell Therapy With Cellistem-OA for Symptomatic Knee Osteoarthritis

April 23, 2021 updated by: Martha Ligia Arango Rodríguez, Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle

Cell Therapy for Patients With Symptomatic Knee Osteoarthritis: Phase I / II, Controlled, Randomized and Double-blind Clinical Trial

Symptomatic knee osteoarthritis is a serious public health problem in the world, it carries a high personal, social and economic impact. Currently, there are no drugs that modify the natural course of the disease. As analgesic therapy becomes insufficient, more invasive measures are applied, ultimately leading to arthroplasty.

The scientific community has joined efforts to develop new therapeutic approaches that allow the delay and regeneration of injured tissue in these patients. These include cell therapy with mesenchymal stem cells derived from different sources. Although most of the clinical studies carried out in different parts of the world with this therapy in patients with knee osteoarthritis have shown therapeutic benefit, it is necessary to develop clinical trials with high quality in our population.

The aim of this project is to evaluate the safety, tolerance and efficacy of Cellistem-OA (biological therapy based on mesenchymal stem cells derived from Wharton's jelly of umbilical cord) in patients with knee osteoarthritis in the Colombian population.

Investigators proposed to carry out an experimental (clinical trial), randomized, controlled and parallel with 30 participants with knee knee osteoarthritis of the medical complex Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle. The participants will be randomized into two groups: i) 15 patients who will receive a dose of 2 x 106 Cellistem-OA and ii) 15 patients who will receive an active comparator (acetonide of triamcinolone 10mg / mL), which will be administered by intra-articular injection in the superolateral aspect of the knee. The outcomes to be evaluated will be: (i) decrease in joint pain, (ii) increase in joint functionality, (iii) improvement in quality of life and (iv) improvement of articular cartilage. These parameters will be evaluated at weeks 1, 4, 8, 12, 24, 25, 28, 32, 36 and 52 post-treatments. Additionally, local and systemic adverse events will be recorded to establish whether or not there is an association between them and the intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Type of study Controlled, randomized, double-blind clinical trial comparing CELLISTEM-OA and active comparator (triamcinolone acetonide).

Study population Patients from the Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle who consult the trauma and rheumatology service by knee osteoarthritis. Patients who show interest in participating will be cited to an interview with the researchers where both the objectives and the research procedures will be explained.

Sample size The sample size considered are 30 participants distributed in two groups.

Group 1 (control) active comparator: triamcinolone acetonide (10mg / mL) via intra-articular, 5 cc.

Group 2 (experimental): CELLISTEM-OA via intra-articular, doses of 2 x 106 cells in 5cc of saline solution.

The intra-articular puncture will be performed by an orthopedic doctor specializing in knee and hip treatments using sterile technique, after cooling the skin with local ice.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

26 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients who / with:

  • Osteoarthritis of the knee.
  • Kellgren II or III to knee radiography.
  • 30 to 75 years inclusive.
  • Pain scale greater than 40 over 100 mm.
  • MRI with G I, II or III chondral knee injury with or without stable degenerative meniscal injury.
  • Stable knee.
  • Examination of the rest of the normal limb.
  • Willingness to participate in the study for 1 year.
  • Ability to understand and willingness to sign the informed consent.

Exclusion Criteria:

Patients who / with:

  • Symptomatic contralateral knee osteoarthritis.
  • Significant knee trauma in the preceding 3 months.
  • Wound or skin lesion in the knee studied.
  • Anatomical valgus greater than 10º.
  • Anatomical varus greater than 5º.
  • Clinically significant joint effusion.
  • Edema greater than 20% of the surface of the plateau or condyle in NMR.
  • Previously known alterations in the hip and / or spine.
  • Predominant patellofemoral pathology (radiographs with IWANO II osteoarthritis or more).
  • Any type of inflammatory arthritis.
  • History of active infections including HIV, HBV and HCV.
  • Results of laboratory tests (hemogram and CRP) outside the normal ranges.
  • Presence of fever on day -1 or day 0.
  • Use of oral corticosteroids.
  • Use of anticoagulants.
  • Immunosuppression, uncontrolled diabetes mellitus, hyperthyroidism, psychiatric illnesses
  • Active neoplasia or during the preceding 5 years.
  • Pregnancy or breastfeeding (b-Hcg positive).
  • Use of drugs or alcoholism.
  • IA injections or knee surgeries in the last 180 days.
  • BMI> 35.
  • Any type of metallic implant susceptible to displacement with MRI.
  • Use of pacemakers.
  • History of severe allergy or anaphylactic shock.
  • Significant alterations in the evaluation of the initial laboratory tests.
  • Any factor that, in the opinion of the investigator, may affect the adequate follow-up of the patient during the study

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: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group 1 (control-Triamcinolone acetonide)
Triamcinolone acetonide (10mg / mL) via intra-articular, 5 cc, one dose (zero time).
Drug: Triamcinolone acetonide
The intra-articular puncture will be performed by an orthopedic doctor specializing in knee and hip treatments. The procedure will be carried out using sterile technique, after cooling the skin with local ice.
Other Names:
  • Kenacort-A
Experimental: Group 2 (experimental- CELLISTEM-OA)
CELLISTEM-OA via intra-articular, doses of 2 x 106 mesenchymal stem cells in 5cc of saline solution, one dose (zero time).
Biological: CELLISTEM-OA
The intra-articular puncture will be performed by an orthopedic doctor specializing in knee and hip treatments. The procedure will be carried out using sterile technique, after cooling the skin with local ice.
Other Names:
  • Mesenchymal stem cells

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Decrease in joint pain
Time Frame: 12 months
Pain will be measured through visual analog scale (VAS).
12 months
Increased joint functionality
Time Frame: 12 months
Joint functionality will be measured through the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
12 months
Improvement in the quality of life
Time Frame: 12 months
Quality of life will be measured through the Short Form 36 Health Survey Questionnaire (SF-36).
12 months
Imaging improvement of articular cartilage
Time Frame: 12 months
The improvement of articular cartilage will be evaluated by nuclear magnetic resonance (NMR).
12 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cells for Cells

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Martha L Arango, PhD, Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OA-01

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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