Intra-articular Injection of MSCs in Treatment of Knee OA

NCT03028428 | Unknown Phase 2

• 1 other identifier: AHJiangsuU-FSK-MSC-OA
• Study Type: interventional
• Target: 1
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis; Stem Cells; MSC

Keywords

Osteoarthritis; Stem Cell; Knee; Mesenchymal Stem Cell

Outcome Measures

Primary Outcomes (1)

• adverse events

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

  1 Year

Secondary Outcomes (4)

• radiographic evidence

  1 Year

• WOMAC assessment

  1 Year

• VAS

  1 Year

• SF-36

  1 Year

Study Arms (2)

Placenta Derived Mesenchymal Stem Cell

EXPERIMENTAL

Placenta Derived Mesenchymal Stem Cell administered into the knee joint once

Biological: Placenta Derived Mesenchymal Stem Cell

sodium hyaluronate

ACTIVE COMPARATOR

Sodium hyaluronate administered into the knee joint once

Drug: Sodium Hyaluronate

Interventions

Placenta Derived Mesenchymal Stem Cell BIOLOGICAL

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

Also known as: Mesenchymal Stromal Cells (MSCs)

Placenta Derived Mesenchymal Stem Cell

Sodium Hyaluronate DRUG

Sodium hyaluronate administered into the knee joint once

Also known as: hyaluronate

sodium hyaluronate

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Affiliated Hospital of Jiangsu University: lead

MeSH Terms

Conditions

Osteoarthritis

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• YU TANG, Dr.

  Affiliated Hospital of Jiangsu University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: 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

Study Record Dates

• First Submitted: January 20, 2017
• First Posted: January 23, 2017
• Study Start: December 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: January 30, 2018

Record last verified: 2018-01