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Intra-articular Injection of MSCs in Treatment of Knee OA

Primary Purpose

Osteoarthritis, Stem Cells, MSC

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Placenta Derived Mesenchymal Stem Cell

Sodium Hyaluronate

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, Stem Cell, Knee, Mesenchymal Stem Cell

Eligibility Criteria

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

Inclusion Criteria:

Patients between 40-75 years of age with symptomatic moderate to severe (Kellgren-Lawrence III or IV) primary osteoarthritis of the knee
Idiopathic or secondary osteoarthritis of the knee with grade 2,3, or 4 radiographic severity, as defined by the modified Kellgren-Lawrence classification
No history of prior intra-articular cortisone, hyaluronic acid, or platelet-rich plasma injection within the previous six months
No history of prior arthroscopic knee surgery or open knee surgery on the ipsilateral side within the past year
Adequate bone marrow, liver, and renal functions
Body weight >40 kg
Body Mass Index <40
Negative for (HIV, HTLV1&2, Hep A, B, C, syphilis) infection as determined by approved serological testing
Negative for pregnancy as determined by a serum pregnancy test. Females of childbearing potential will be required to practice abstinence or use an effective form of contraception for 12 months following their MSC injection.
Ability to provide written informed consent.

Exclusion Criteria:

Patients with clinically unstable knee due to the presence of a complete anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament and/or posterolateral corner tear
Patients with varus or valgus malalignment >5 degrees as measured by 4 foot standing antero-posterior radiographs
Patients with a history of a previous subtotal medial or lateral meniscectomy
Patients with a history of septic arthritis in the affected joint
Patients with a history of a prior intra-articular knee fracture
Severe bleeding diathesis
Contraindication to bone marrow aspiration and/or biopsy
Active infection
Bone marrow failure
Cytopenia
Patients who have previously received radiotherapy to the pelvis
Patients who have been on chemotherapy from within a year of the date of informed
Patients with positive serological test for (HIV, HTLV1&2, Hep A, B, C, syphilis)
Pregnancy or risk of pregnancy (this includes participants that are not willing to practice active contraception for the duration of the study)
Patients with unforeseen conditions that are deemed unsafe or inappropriate for the study (e.g. patients who are claustrophobic and cannot undergo an MRI) as per the discretion of the principal investigator

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Placenta Derived Mesenchymal Stem Cell

sodium hyaluronate

Arm Description

Placenta Derived Mesenchymal Stem Cell administered into the knee joint once

Sodium hyaluronate administered into the knee joint once

Outcomes

Primary Outcome Measures

adverse events

Number of participants with adverse events as measure of safety and tolerability

Secondary Outcome Measures

radiographic evidence

Number of participants with a change in cartilage thickness of knee OA using MRI

WOMAC assessment

Number of participants with a change in joint function from baseline WOMAC assessment

VAS

Number of participants with a change in arthritis pain scores on the visual analogue scale

SF-36

Number of participants with a change in SF-36

Full Information

NCT ID

NCT03028428

First Posted

January 20, 2017

Last Updated

January 27, 2018

Sponsor

Affiliated Hospital of Jiangsu University

1. Study Identification

Unique Protocol Identification Number

NCT03028428

Brief Title

Intra-articular Injection of MSCs in Treatment of Knee OA

Official Title

Clinical Research on Intra-articular Injection of Human Autologous MSCs in Treatment of Knee OA

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Unknown status

Study Start Date

December 2016 (undefined)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Affiliated Hospital of Jiangsu University

4. Oversight

5. Study Description

Brief Summary

In this study, researchers want to determine the safety of MSCs that a patient can tolerate without causing side effects. Moreover researchers will also be looking at the function of the knee over time, which may give them some insight on the usefulness of MSCs as a treatment option.

Detailed Description

Osteoarthritis (OA) is one of the most common forms of arthritis. It is a lasting condition in which the material that cushions the joints, called cartilage, breaks down. This causes the bones to rub against each other, causing inflammation, stiffness, pain and loss of joint movement. Currently, there are few effective treatments available for patients suffering from OA. Mesenchymal stem cells (MSCs) are cells that have the ability to self-regenerate, which means they have the ability to make copies of themselves and to turn into other kinds of cells (e.g. cartilage cells). Stem cell science shows much promise for the future treatment of osteoarthritis, but much of the research is still in the early stages. In this study, researchers want to determine the safety of MSCs that a patient can tolerate without causing side effects. Moreover researchers will also be looking at the function of the knee over time, which may give them some insight on the usefulness of MSCs as a treatment option.

6. Conditions and Keywords

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

Osteoarthritis, Stem Cells, MSC

Keywords

Osteoarthritis, Stem Cell, Knee, Mesenchymal Stem Cell

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

A Randomized, Double Blind, Phase-II Study Assessing the Safety and Efficacy of Intraarticular Ex-vivo Cultured Adult Allogeneic Mesenchymal Stem Cells in Patients with Osteoarthritis of Knee

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Double blind

Allocation

Randomized

Enrollment

1 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placenta Derived Mesenchymal Stem Cell

Arm Type

Experimental

Arm Description

Placenta Derived Mesenchymal Stem Cell administered into the knee joint once

Arm Title

sodium hyaluronate

Arm Type

Active Comparator

Arm Description

Sodium hyaluronate administered into the knee joint once

Intervention Type

Biological

Intervention Name(s)

Placenta Derived Mesenchymal Stem Cell

Other Intervention Name(s)

Mesenchymal Stromal Cells (MSCs)

Intervention Description

1ml 1*10^7 Placenta Derived Mesenchymal Stem Cell administered into the knee joint once

Intervention Type

Drug

Intervention Name(s)

Sodium Hyaluronate

Other Intervention Name(s)

hyaluronate

Intervention Description

Sodium hyaluronate administered into the knee joint once

Primary Outcome Measure Information:

Title

adverse events

Description

Number of participants with adverse events as measure of safety and tolerability

Time Frame

1 Year

Secondary Outcome Measure Information:

Title

radiographic evidence

Description

Number of participants with a change in cartilage thickness of knee OA using MRI

Time Frame

1 Year

Title

WOMAC assessment

Description

Number of participants with a change in joint function from baseline WOMAC assessment

Time Frame

1 Year

Title

VAS

Description

Number of participants with a change in arthritis pain scores on the visual analogue scale

Time Frame

1 Year

Title

SF-36

Description

Number of participants with a change in SF-36

Time Frame

1 Year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients between 40-75 years of age with symptomatic moderate to severe (Kellgren-Lawrence III or IV) primary osteoarthritis of the knee Idiopathic or secondary osteoarthritis of the knee with grade 2,3, or 4 radiographic severity, as defined by the modified Kellgren-Lawrence classification No history of prior intra-articular cortisone, hyaluronic acid, or platelet-rich plasma injection within the previous six months No history of prior arthroscopic knee surgery or open knee surgery on the ipsilateral side within the past year Adequate bone marrow, liver, and renal functions Body weight >40 kg Body Mass Index <40 Negative for (HIV, HTLV1&2, Hep A, B, C, syphilis) infection as determined by approved serological testing Negative for pregnancy as determined by a serum pregnancy test. Females of childbearing potential will be required to practice abstinence or use an effective form of contraception for 12 months following their MSC injection. Ability to provide written informed consent. Exclusion Criteria: Patients with clinically unstable knee due to the presence of a complete anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament and/or posterolateral corner tear Patients with varus or valgus malalignment >5 degrees as measured by 4 foot standing antero-posterior radiographs Patients with a history of a previous subtotal medial or lateral meniscectomy Patients with a history of septic arthritis in the affected joint Patients with a history of a prior intra-articular knee fracture Severe bleeding diathesis Contraindication to bone marrow aspiration and/or biopsy Active infection Bone marrow failure Cytopenia Patients who have previously received radiotherapy to the pelvis Patients who have been on chemotherapy from within a year of the date of informed Patients with positive serological test for (HIV, HTLV1&2, Hep A, B, C, syphilis) Pregnancy or risk of pregnancy (this includes participants that are not willing to practice active contraception for the duration of the study) Patients with unforeseen conditions that are deemed unsafe or inappropriate for the study (e.g. patients who are claustrophobic and cannot undergo an MRI) as per the discretion of the principal investigator

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

YU TANG, Dr.

Organizational Affiliation

Affiliated Hospital of Jiangsu University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Intra-articular Injection of MSCs in Treatment of Knee OA

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