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The Safety/Efficacy of Human Umbilical Cord Mesenchymal Stem Cells Therapy for Patients With Osteoarthritis

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ClinicalTrials.gov Identifier: NCT03383081
Recruitment Status : Not yet recruiting
First Posted : December 26, 2017
Last Update Posted : December 26, 2017
Sponsor:
Information provided by (Responsible Party):
Sclnow Biotechnology Co., Ltd.

Brief Summary:
The purpose of this study is verify the efficacy and safety of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSC) therapy for patients with Osteoarthritis, and in addition, provide basis for exploring the treatment regimen of UC-MSC therapy in different degree of cartilage defect disease

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Biological: Low dose mesenchymal stem cells Biological: High dose mesenchymal stem cells Procedure: Intraarticular injection Phase 2

Detailed Description:

This is a random, open label, and parallel controled experiment. All patients are selected and sign consent forms, then divided into 3 groups. Doctors collect the basic information of patient. All patients receive laboratory and image examination as baseline. Then, they will give cell treatment based on the clinical protocol. Doctors have follow-up visit on 2 weeks, 1, 2, 3, 6, and 12 months after treatment, and do safety and efficacy evaluation.

Safety evaluation. Researcher collect all examination data of patients and compare with each groups. The safety tests including blood routine, urine routine, hepatorenal function, C reactive protein, erythrocyte sedimentation rate, and tumor marker, etc.

Efficacy evaluation. Based on Lysholm, the international knee documentation committee (IKDC) knee evaluation form, and Visual Analogue Scale/Score (VAS) to examine the change/improvement of knee joint function. By Magnetic Resonance Imaging (MRI) examination, grade patients with Kellgren-Lawrence Grading Scale, Assessment of Preoperative Cartilage Defect Severity (AMADEUS), and observe the change/improvement of patient.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Research on the Safety/Efficacy of Human Umbilical Cord Mesenchymal Stem Cells Therapy for Patients With Osteoarthritis
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Low dose mesenchymal stem cells
Low dose group: intra-articular injection with human umbilical cord mesenchymal stem cells (SCLnow 19#)
Biological: Low dose mesenchymal stem cells
Human umbilical cord mesenchymal stem cells (SCLnow 19#): group A, 1 * 10^7 cells (5ml);
Procedure: Intraarticular injection
Intraarticular injection with human umbilical cord mesenchymal stem cells (SCLnow 19#) with different dose group
Experimental: High dose mesenchymal stem cells
High dose group: intra-articular injection with human umbilical cord mesenchymal stem cells (SCLnow 19#)
Biological: High dose mesenchymal stem cells
Human umbilical cord mesenchymal stem cells (SCLnow 19#): group B, 2 * 10^7 cells (5ml)
Procedure: Intraarticular injection
Intraarticular injection with human umbilical cord mesenchymal stem cells (SCLnow 19#) with different dose group
No Intervention: Control groups
No intervention



Primary Outcome Measures :
  1. Kellgren-Lawrence Grading Scale [ Time Frame: 12 months ]

    Using Magnetic Resonance Imaging (MRI) examination, and based on the images of bilateral knee joint, grade by Kellgren-Lawrence Grading Scale. Kellgren-Lawrence Grading Scale is a method of classifying the severity of knee osteoarthritis (OA).

    Grade 0: No radiographic features of osteoarthritis; Grade 1: Possible joint space narrowing (normal joint space is at least 2 mm at the superior acetabulum) and osteophyte formation; Grade 2: Definite osteophyte formation with possible joint space narrowing; Grade 3: Multiple osteophytes, definite joint space narrowing, sclerosis and possible bony deformity; Grade 4: Large osteophytes, marked joint space narrowing, severe sclerosis and definite bony deformity.



Secondary Outcome Measures :
  1. Assessment of Preoperative Cartilage Defect Severity (AMADEUS) [ Time Frame: 12 months ]
    Using Magnetic Resonance Imaging (MRI) examination to diagnose patients by Assessment of Preoperative Cartilage Defect Severity (AMADEUS).

  2. Lysholm scoring [ Time Frame: 12 months ]
    Using Lysholm Knee Scoring Scale to grade the knee function of patients, and examine the changes or improvement compare to baseline.

  3. The international knee documentation committee (IKDC) knee evaluation form [ Time Frame: 12 months ]
    The international knee documentation committee knee evaluation form is used to assess the knee function of patients, examine the changes or improvement compare to baseline.

  4. Visual Analogue Scale/Score(VAS) [ Time Frame: 12 months ]
    Using Visual Analogue Scale/Score for pain to examine the change/improvement of knee joint function.



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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Knee Osteoarthritis by Kellgren and Lawrence Grading Scale, classified with Grade 2-3
  • Confirm with cartilage injury,articular cartilage part or full-thickness injury, by MR (Magnetic Resonance)
  • Age <70, no serious organ dysfunction
  • Over 2 years knee pain or no very effective with conservative treatments
  • Knee pain of VAS (visual analog scale score) is 4 or higher
  • Normal hepatic and renal function, no history of gout, rheumatoid arthritis, and autoimmune diseases, etc.
  • Understand and sign the consent form of this study

Exclusion Criteria:

  • Refuse to sign the consent form, or cannot keep follow-up visit
  • Age >70; Age <70, but with multiple organ failure
  • Unstable vital signs (breath, blood pressure, pulse)
  • Combined with knee ligament (anterior and the posterior cruciate ligament, medial and lateral collateral ligament) rupture, laxity, etc.
  • Serious bleeding tendency, poor coagulation function (PTA <35%)
  • Pregnant or breast feeding women, or positive pregnancy test in 7 days before treatment
  • Participate other clinical experiments in 3 months
  • With progressing malignant tumor
  • Combined with shock and critically ill patients
  • With mental disease, cannot
  • With history of knee joint infection, surgery, and radiotherapy
  • With immunosuppressive agents treatment in 6 weeks
  • Injection with hormones and sodium hyaluronate in joint in 3 months
  • Overweight expressed as body mass index (BMI) >35
  • With skin disease around knee joint
  • With Immunodeficiency disease, including long term use immunosuppressive agents patients
  • Combined with serious infection
  • With some other conditions that doctor propose not to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03383081


Contacts
Contact: Lei Guo 861064368977 georgeguo@sclnow.com

Sponsors and Collaborators
Sclnow Biotechnology Co., Ltd.
Investigators
Principal Investigator: Hongbin Lv Xiangya Hospital of Central South University

Responsible Party: Sclnow Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03383081     History of Changes
Other Study ID Numbers: SCLnow-XY-02
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sclnow Biotechnology Co., Ltd.:
osteoarthritis, mesenchymal stem cell

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases