Allogenic Mesenchymal Stem Cell Intraarticular Injection for Knee Osteoarthritis Therapy (STEMJOINT)

June 8, 2024 updated by: Rasmus Roost Aabling, Aarhus University Hospital

Allogenic Mesenchymal Stem Cell Intraarticular Injection for Knee Osteoarthritis Therapy, an RCT Explorative Mode-of-action Study

This phase I and II double blinded randomized clinical controlled trial investigates the safety and efficacy of intraarticular knee injection with allogenic adipose derived mesenchymal stem cells (AD-MSC), in patients suffering from mild-moderate knee osteoarthritis compared to placebo injection with saline.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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.

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 (Estimated)

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.
80

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

Study Locations

  • Denmark
      • Aarhus N, Denmark, 8200
        • Recruiting
        • Aarhus University
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Chronic knee pain (defined for at least 6 months with NRS 4 or above when pain worst)
  • Patients with Grade II-III osteoarthritis according to the Kellgren Lawrence Classification and a joint width space of 1-3 mm.
  • Axial hip, knee, ankle x-ray with no more than 5 degrees valgus/varus deformity
  • Medial, lateral or dual compartment OA as determined above
  • BMI <35
  • Danish speaker
  • Patients must be legally competent and must be able to sign the written consent

Exclusion Criteria:

  • Severe Osteoarthritis (Grade IV according to Kellgren Lavrence Classification)
  • Intraarticular tumor, infection or fracture
  • Pregnancy and breast feeding
  • Cognitive impairment
  • Treatment with cytostatic drugs
  • Previous intraarticular knee injection in the past 3 mo.
  • Unable to perform MRI scan (non-compatible implants, claustrophobia and severe obesity(>BMI 35)
  • Previous ligament reconstruction
  • Meniscal operation with resection with more than 50% or multiple meniscal operations (more than one resection)
  • Diabetes mellitus type 1 and 2
  • Knee instability on physical examination
  • History of allergy to antibiotics
  • Concomitant severe infection, malignant tumor, coagulation diseases or uncontrolled or unmanaged systemic disease
  • Presence of other types of inflammatory arthritis

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: Double

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: Intervention

Single intraarticular knee injection with allogenic adipose derived mesenchymal stem cells (AD-MSC)

20 million AD-MSC in 10 mL saline
Biological: Allogenic adipose derived mesenchymal stem cells (AD-MSC)
Laboratory isolated, cultivated and cryopreserved allogenic adipose derived mesenchymal stem cells (AD-MSC) from health donors undergoing cometic plastic surgery will be thawed on the injection day and formulated in 10 mL saline. The AD-MSCs will then be intraarticular injected using ultrasonic guidance.
Placebo Comparator: Control

Single intraarticular knee injection with saline alone

10 mL saline
Other: Saline
10 mL saline will be intraarticular injected using ultrasonic guidance.

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
Observation (change) of adverse events
Time Frame: Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years
Pain Diary first 30 days after treatment, any reported adverse events after treatment
Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years
Change in Knee symptoms (questionnaire Knee injury and Osteoarthritis Outcome Score (KOOS) (symptoms)) from baseline
Time Frame: Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years
(questionnaire Knee injury and Osteoarthritis Outcome Score (KOOS) (symptoms))
Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in pain from baseline
Time Frame: Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years
Numeric Rating Scale (NRS)
Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years
Observation (change) of cartilage regeneration compared to baseline
Time Frame: Baseline, 3 months, 12 months, 24 months
MRI Osteoarthritis Knee Score
Baseline, 3 months, 12 months, 24 months
Observation (change) of quantitative cartilage regeneration compared to baseline
Time Frame: Baseline, 3 months, 12 months, 24 months
Quantitative MRI (unit: stress and strain and volumen cartilage)
Baseline, 3 months, 12 months, 24 months
Improvement (change) during clinical examination with range of motion compared to baseline
Time Frame: Baseline, 3 months, 12 months, 24 months
Range of motion (unit: degrees)
Baseline, 3 months, 12 months, 24 months
Improvement (change) during clinical examination with Effusion tests (swelling) compared to baseline
Time Frame: Baseline, 3 months, 12 months, 24 months
Effusion tests (swelling) (unit: effusion (YES/NO))
Baseline, 3 months, 12 months, 24 months
Improvement (change) during clinical examination with measurement of knee diameter (swelling) compared to baseline
Time Frame: Baseline, 3 months, 12 months, 24 months
Measure knee diameter (unit: cm)
Baseline, 3 months, 12 months, 24 months
Improvement (change) during clinical examination with measurement of quadriceps muscle diameter (atrofi) compared to baseline
Time Frame: Baseline, 3 months, 12 months, 24 months
Measure quadriceps muscle (unit: cm)
Baseline, 3 months, 12 months, 24 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.
Aarhus University Hospital

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: Rasmus Aabling, MD, University of Aarhus

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 (Actual)

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.
March 7, 2024

Primary Completion (Estimated)

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.
October 1, 2030

Study Completion (Estimated)

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.
October 1, 2030

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).
June 5, 2023

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.
June 26, 2023

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.
July 6, 2023

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.
June 11, 2024

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.
June 8, 2024

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.
June 1, 2024

More Information

Terms related to this study

Keywords

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.
  • STEMJOINT01

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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