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Investigator Initiated Trial to Evaluate the Efficacy and Safety of Intra-articular Injection of ADMSC Comared to Negative Control After High Tibial Osteotomy in the Osteoarthritis Patients.

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ClinicalTrials.gov Identifier: NCT03000712
Recruitment Status : Active, not recruiting
First Posted : December 22, 2016
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
R-Bio

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of intra-articular injection of autologous adipose tissue derived mesenchymal stem cells compared after high tibial osteotomy to negative control in the osteoarthritis patients

Condition or disease Intervention/treatment Phase
Degenerative Arthritis Knee Osteoarthritis Biological: Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml Not Applicable

Detailed Description:

In this clinical trial, the investigational product is administered intra-articularly at 1 week after high tibial osteotomy in a patient with degenerative arthritis of the medial side.

The investigational product is autologous adipose-derived mesenchymal stem cells. As it does not use allogenic tissue and is incubated without additional genetic modification or mechanical and chemical modification through differentiation, it is classified as 'autologous cell therapy' and is completely free of immunologic rejection.

It primarily aims to regenerate cartilage, to improve pain and joint function. The intra-articular injection of the investigational product is expected to stimulate the regeneration and growth of cartilage, and to innovatively improve pain and joint function with cartilage regeneration compared to high tibial osteotomy alone.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single-center, Randomized, Open Label, Negative-controlled Investigator Initiated Trial to Evaluate the Efficacy and Safety of Intra-articular Injection of ADMSC(Autologous Adipose Tissue Derived Mesenchymal Stem Cells) After High Tibial Osteotomy Compared to Negative Control in the Osteoarthritis Patients.
Actual Study Start Date : November 2, 2016
Estimated Primary Completion Date : February 22, 2020
Estimated Study Completion Date : April 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Autologous Adipose Tissue derived MSCs
Biological: Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml, 1 time injection(at 1week after high tibial osteotomy)
Biological: Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml
biological : Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml drug: saline solution
Other Name: JOINTSTEM

No Intervention: No treatment
No treatment (after high tibial osteotomy)



Primary Outcome Measures :
  1. MRI scan [ Time Frame: 24 months ]
    MRI perform to measure cartilage defect size change from baseline up to 27 weeks


Secondary Outcome Measures :
  1. MRI scan [ Time Frame: 15, 27 weeks, 18, 24 months ]
    MRI perform to measure cartilage defect size change from baseline up to 15 weeks

  2. WOMAC score [ Time Frame: 15, 27 weeks, 18, 24 months ]
    Change in WOMAC Total score from baseline up to 15, 27 weeks

  3. WOMAC sub-scale [ Time Frame: 15, 27 weeks, 18, 24 months ]
    Change in WOMAC sub-scale from baseline up to 15, 27 weeks

  4. Kellgren & Lawrence grade [ Time Frame: 15, 27 weeks, 18, 24 months ]
    Change in Kellgren & Lawrence grade from baseline up to 15, 27 weeks

  5. EQ5D [ Time Frame: 15, 27 weeks, 18, 24 months ]
    Change in the score of EQ-5D from baseline up to 15, 27 weeks

  6. ROM [ Time Frame: 15, 27 weeks, 18, 24 months ]
    change from baseline in knee flexion Range of Motion(ROM) at 15,27 weeks by physical examination

  7. KOOS (Knee Injury & Osteoarthritis Outcome Score) [ Time Frame: 15, 27 weeks, 18, 24 months ]
    Symptoms, pain and functionality of the knee joint will be evaluated via the Knee Injury and Osteoarthritis Outcome Score (KOOS)

  8. PGIC(Patient Global Impression of Change) [ Time Frame: 15, 27 weeks, 18, 24 months ]
    The percentage of subjects who were evaluated as improved at 15 weeks and 27 weeks in the patient global impression of change

  9. PSQI(Pittsburgh Sleep Quality Index) [ Time Frame: 15, 27 weeks, 18, 24 months ]
    Change in PSQI from baseline up to 15, 27 weeks

  10. Biomarkers [ Time Frame: 15, 27 weeks, 18, 24 months ]
    Change from baseline in Biomarkers up to 15, 27 weeks

  11. Incidence of adverse reactions and characteristics associated with investigational product [ Time Frame: 15, 27 weeks, 18, 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must consent in writing to participate in the study by signing and dating an informed consent document
  2. Patients who can communicate (exclusion of anyone who cannot understand the questionnaire)
  3. between 20 years and 80 years of age
  4. BMI≤30
  5. Diagnosis of osteoarthritis by radiographic criteria of Kellgren and Lawrence grade 2-4
  6. Diagnosis of osteoarthritis by ACR(American College of Rheumatology Criteria) Global functional criteria : There is the pain of the knee and radiographic osteophyte and at least one of the following (1) age >50 years (2) Less than 30 minutes of morning stiffness (3) The friction When moving weighted the knee
  7. Patients who agree with contraception
  8. Patients who agree to stop the existing osteoarthritis treatment and to get enough washout periods until medication time
  9. Patients scheduled for High tibial osteotomy due to medial gonarthrosis

Exclusion Criteria:

  1. patients with osteoporosis
  2. Preparing for Pregnancy or Pregnant women or lactating mothers.
  3. Patients with positive human immunodeficiency (HIV), hepatitis B (HBV), hepatitis C (HCV), venereal disease research laboratory(VDRL)
  4. Patients with hypersensitivity to investigator product or investigational product component or those with a history
  5. Patients who had participated in other clinical trials within 12 weeks prior to this study
  6. Patients who received any drug by intra-articular injection for treatment within 2 months prior to this enrollment.
  7. Patients who experienced as the knee joint cartilage and stem cell therapy or failure to treat
  8. Patents who started or changed the physical therapy program established within 2 weeks before the start of the study or during the study(An established physical therapy program may continue for the duration of the trial, provided that it does not change in frequency and intensity)
  9. Patents included in the following specific risk groups that may influence safety and efficacy assessments at the discretion of the investigator:: septic arthtritis, rheumatic disease, gout, recurrent pseudogout, paget disease, joint fracture, alcaptonuria, acromegaly, hemochromatosis, wilson's disease, primary osteochondrosis, hereditary disorder(ex: hyperkinesia), collagen gene abnormality ,etc
  10. Patients who have clinically significant severe medical illnesses judged the principal investigator
  11. Patients who have been diagnosed with malignancy within 5 years before screening (except for patients who were completely remissioned three years before screening criteria)
  12. Patients who the principal investigator consider inappropriate for the clinical trial due to any other reasons
  13. Patients who received concomitant contraindications and who have not passed the prescribed wash-out period before participating in the clinical trial

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): NCT03000712


Locations
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Korea, Republic of
KyungHee University Gangdong Hospital
Seoul, Korea, Republic of, 134-727
Sponsors and Collaborators
R-Bio
Investigators
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Principal Investigator: KANGIL KIM, M.D., Ph.D KyungHee University Gangdong Hospital

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Responsible Party: R-Bio
ClinicalTrials.gov Identifier: NCT03000712     History of Changes
Other Study ID Numbers: HTO-MSCs
First Posted: December 22, 2016    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by R-Bio:
adipose tissue derived mesenchymal stem cell
osteoarthritis
degenerative arthritis
kyung hee university hospital
biostar
Rbio
Osteoarthritis, Knee
High tibial osteotomy
Joint Diseases

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