Knee Osteoarthritis Treatment With Percutaneous Injections of Autologous Bone Marrow Concentrate (Bone-Gun)

March 14, 2020 updated by: Istituto Clinico Humanitas

Pilot Study on the Treatment of Knee Osteoarthritis With Percutaneous Injections of Autologous Bone Marrow Concentrate at the Cartilage-bone Interface.

Recently there has been a growing interest in the role of subchondral bone in knee arthritis, both in its etiology and evolution and in its clinical significance. It has now been widely demonstrated that changes in the subchondral bone can develop both as a cause and as a consequence of joint degeneration and it is now accepted in the scientific community that the presence of these changes is of clinical importance, causing pain and an inflammatory state that can contribute to the evolution of arthrosis arthropathy. Recently the use of mesenchymal cells obtained from the bone marrow has been proposed for the treatment of gonarthrosis by intra-articular injections. Even more recently, treatments have been studied and proposed for the treatment of the bone-cartilage interface in knees affected by osteoarthrosis, using autologous bone marrow concentrate, with promising results.

Study Overview

Status

Status

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

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

Osteoarthritis (OA) is a chronic degenerative and disabling disease of joint joints, in which metabolic impairment between the synthesis and degradation of cartilage and subchondral bone, involves progressive destruction of joint tissue accompanied by chronic pain and synovial inflammation. Currently, available therapies are mostly palliative and designed to mask symptoms. The study proposed here has been constructed on the basis of the scientific evidence reported in the literature regarding the etiology and the treatment of OA. As recently demonstrated, the use of mesenchymal cells obtained from the bone marrow was effective in the treatment of gonarthrosis by intra-articular injections. Even more recently, treatments aimed at treating the bone-cartilage interface in arthritic knees have been studied and proposed. In the 2016 Val et al. pilot study, stem cells from the tibial bone marrow injected into the percutaneous bone-cartilage interface were described as a new therapeutic approach to osteoarthritis of the knee. This procedure is able to repair cartilage by stimulating subchondral bone angiogenesis and alleviating ischemia associated with arthritic knee pain, generating extremely positive outcomes in patients with low-grade osteoarthritis and relieving long-term pain in patients with high-grade osteoarthritis. This treatment is also able to induce differentiation and proliferation of chondrocytes, leading to an increase in the size of the intra-articular matrix, demonstrating an effective and minimally invasive treatment for the resolution of OA. The study described here aims to evaluate the potential effectiveness of the synergistic effect of both injections, with the aim of improving the symptomatic picture of patients with OA of the knee. Combining percutaneous injections at the bone-cartilage interface with intra-articular injections will provide proven results for the use of stem cells such as cartilage repair, increased vascularity, and pain reduction, in both compartments of the knee affected by OA. The positive effects reported in the literature regarding intra-articular injections will be combined with those reported with respect to the use of percutaneous injections at the cartilage, in order to obtain a better outcome in the treatment of the disease than in previous studies.

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.
Observational

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.
25

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

  • Italy
    • Milan
      • Rozzano, Milan, Italy, 20089
        • Recruiting
        • Humanitas Research Hospital
        • Contact:
          • Elizaveta Kon, MD
          • Phone Number: +390282247523

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

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

25 patients, meeting specific inclusion and exclusion criteria, will be enrolled. In general, the patients are characterized as patients with painful arthritis of the medial or lateral compartment, which have not achieved a reduction in pain in the presence of conservative treatments. The patients are enrolled on the basis of a paper questionnaire based on the inclusion and exclusion criteria: a patient can only be enrolled if he or she responds positively to all questions related to the inclusion criteria and negatively to all questions related to the exclusion criteria.

Description

Inclusion Criteria:

  1. Male or female patients aged between 40 and 70;
  2. Medial or lateral arthrosis (grade 2-3 according to Kellgren-Lawrence score);
  3. Failure after at least 6 months of conservative treatment (patients not responding to drug therapy with NSAIDs and painkillers, no benefit from rehabilitation cycle in water or gym, no benefit after hyaluronic acid or platelet-rich plasma (PRP) infiltrations, or after at least one infiltration of corticosteroids);
  4. Ability and consent of patients to participate actively in the rehabilitation and clinical and radiological follow-up protocol;
  5. Signing of informed consent.

Exclusion Criteria:

  1. Patients who are incapable of understanding and will;
  2. Trauma patients within 6 months prior to surgery;
  3. Patients with malignancies;
  4. Patients with rheumatic diseases;
  5. Patients with diabetes;
  6. Patients with metabolic thyroid disorders;
  7. Patients abusing alcoholic beverages, drugs or drugs;
  8. Patients with lower limb impairment above 10°
  9. Body Mass Index <18 or > 35;
  10. Patients undergoing knee surgery during the 12 months prior to surgery;
  11. Patients with pathology ascribable to patellofemoral pathology;
  12. Untreated knee instability.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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
Improvement of subjective International Knee Documentation Committee (IKDC)
Time Frame: up to 24 months
The IKDC subjective knee Form consists of questions, divided into four sections: Symptoms, Functionality during daily activities and sports, Current knee function, Participation in work and sports. The patient will fill the subjective IKDC questionnaire.
up to 24 months

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
improvement according to the subscale Knee injury and Osteoarthritis Outcome Score (KOOS) pain
Time Frame: up to 24 months
The KOOS score consists of 5 categories; Pain, Other symptoms, Functionality in daily activities, Functionality in sports and recreational activities, and Quality of life. The previous week shall be taken into account as a reference at the time of compilation. For each question, several answer options are provided within each category, corresponding to a score between 0-4 points; overall the score is between 100 and 0 (100 indicates absence of symptoms, 0 indicates total presence of symptoms). The patient will fill the KOOS questionnaire.
up to 24 months
improvement of the overall KOOS
Time Frame: up to 24 months
The KOOS score consists of 5 categories; Pain, Other symptoms, Functionality in daily activities, Functionality in sports and recreational activities, and Quality of life. The previous week shall be taken into account as a reference at the time of compilation. For each question, several answer options are provided within each category, corresponding to a score between 0-4 points; overall the score is between 100 and 0 (100 indicates absence of symptoms, 0 indicates total presence of symptoms). The patient will fill the KOOS questionnaire.
up to 24 months
improvement of the TEGNER score
Time Frame: up to 24 months
This score allows to estimate the level of motor activity of a subject with a score between 0 and 10 (0 represents 'incapacity' and 10 represents 'participation in competitive sports'). In the study the TEGNER Score will be compiled directly by the Investigator, through an interview to the patient.
up to 24 months
Improvement according to Whole-Organ Magnetic Resonance Imaging Score (WORMS) MRI score
Time Frame: up to 24 months
The WORMS score is composed of seven voices that describe in the complex, the aspect of the joint, evaluating specifically the state of the cartilage with sequences T2-weighted FSE and FS-3D SPGR (taking into consideration thickness and signal) presence of subchondral cysts with suppressed fat sequences T2-weighted FSE, presence of subchondral edema with suppressed fat sequences T2-weighted FSE, joint profile (considering any flattening or depression of the articular surface compared to normal), the presence of osteophytes and their size, the state of the meniscus, both medial and lateral, the state of the synovia by distension of the synovial cavity. The radiologist will fill the WORMS score forms.
up to 24 months
Improvement according to Kellgren-Lawrence (K/L) score
Time Frame: up to 24 months
The score K/L grading scale allows to classify and differentiate the degree of severity of osteoarthritis of the damaged knee. The score includes grade I to grade IV (the higher the grade, the more severe the OA). The radiologist will fill K/L score forms.
up to 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.
Istituto Clinico Humanitas

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: Elizaveta Kon, MD, Istituto Clinico Humanitas

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.
June 6, 2018

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.
September 30, 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.
January 31, 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).
March 10, 2020

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.
March 14, 2020

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.
March 17, 2020

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.
March 17, 2020

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.
March 14, 2020

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.
March 1, 2020

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.
  • 528

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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