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Trial record 70 of 120 for:    stem cell arthritis AND Phase

Adipose-derived Stem Cells (ADSCs) for Knee Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02784964
Recruitment Status : Active, not recruiting
First Posted : May 27, 2016
Last Update Posted : September 24, 2019
Sponsor:
Collaborator:
A2 Healthcare Taiwan Corporation
Information provided by (Responsible Party):
UnicoCell Biomed CO. LTD

Brief Summary:
  1. To assess the safety of allogeneic injection of expanded ADSCs to patients with knee osteoarthritis
  2. To assess the efficacy of allogeneic injection of expanded ADSCs to patients with knee osteoarthritis

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Biological: Elixcyte 8 ml Device: Hya Joint Plus Biological: Elixcyte 4 ml Biological: Elixcyte 2 ml Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Phase I/II Study to Evaluate the Safety and Efficacy of the Allogeneic Injection of Expanded Adipose-derived Stem Cells to Patients With Knee Osteoarthritis
Actual Study Start Date : March 2016
Actual Primary Completion Date : July 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Elixcyte 8mL
ADSC 6.4*10^7 cells, allogeneic injection, one time injection on Day 1
Biological: Elixcyte 8 ml
ADSC 6.4*10^7 cells, allogeneic injection

Active Comparator: Hya Joint Plus
Hya Joint Plus synovial fluid supplement 3mL, SciVision Biotech Inc., one time injection on Day 1
Device: Hya Joint Plus
Hya Joint Plus synovial fluid supplement 3mL, SciVision Biotech Inc.

Experimental: Elixcyte 4mL
ADSC 3.2*10^7 cells, allogeneic injection, one time injection on Day 1
Biological: Elixcyte 4 ml
ADSC 3.2*10^7 cells, allogeneic injection

Experimental: Elixcyte 2mL
ADSC 1.6*10^7 cells, allogeneic injection, one time injection on Day 1
Biological: Elixcyte 2 ml
ADSC 1.6*10^7 cells, allogeneic injection




Primary Outcome Measures :
  1. Changes from baseline to post-treatment visit of WOMAC pain score at week 24 after treatment [ Time Frame: Weeks 0, 24 ]
  2. Incidence of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Week 48 ]

Secondary Outcome Measures :
  1. Changes from baseline to post-treatment visits of Visual Analogue Scale (VAS) to measure Pain Levels [ Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48 ]
  2. Changes from baseline to post-treatment visits of scores of sections in Knee Society Clinical Rating System (KSCRS) Score [ Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48 ]
  3. Changes from baseline to post-treatment visits of MRI examination results [ Time Frame: Weeks 0, 24, 48, 72, 96 ]
  4. Changes from baseline to post-treatment visits of total score, and sub-scores of all sections in WOMAC [ Time Frame: Weeks 0, 2, 4, 12, 36, 48 ]
  5. Total acetaminophen consumption amount during the first 48 weeks and week 48 to week 96 [ Time Frame: Week 0, 2, 4, 12, 24, 48, 96 ]
  6. Total non-steroidal anti-inflammatory drug (NSAID) consumption amount during the first 48 weeks and week 48 to week 96 [ Time Frame: Weeks 0, 2, 4, 12, 24 ]
  7. Time to subject first time consumes acetaminophen [ Time Frame: Weeks 0, 2, 4, 12, 24 ]
  8. Time to subject first time consumes non-steroidal anti-inflammatory drug (NSAID) [ Time Frame: Weeks 0, 2, 4, 12, 24 ]
  9. Number of patients with clinically abnormal laboratory values and/or adverse events that are related to treatment [ Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48, 72, 96 ]
  10. Number of patients with clinically abnormal vital signs and/or adverse events that are related to treatment [ Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48, 72, 96 ]
  11. Changes from baseline to week 96 visit in cartilage thickness in the total femorotibial joint by centralized (independent) imaging interpretation. [ Time Frame: Weeks 0, 24, 48, 72, 96 ]


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged 40-80 years (inclusive)
  2. Kellgren-Lawrence grading I-III, as determined by American College of Rheumatology (ACR) criteria for osteoarthritis of the knee
  3. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score of 7-17 in the study knee even if treated with chronic doses of non steroidal anti-inflammatory drugs
  4. Having provided informed consent

Exclusion Criteria:

  1. With previous surgery of articular fracture, ligament reconstruction, meniscal reconstruction, and knee arthroplasty on the target knee joint
  2. With previous intra-articular intervention on the target knee joint within past 3 months (e.g. steroid, anaesthetic, sodium hyaluronate)
  3. Known or suspected infection of the target knee joint
  4. Ascertained hypersensitivity to any component used in the study
  5. Administered with systemic anti-inflammatory drugs (e.g. non-steroidal anti-inflammatory drug or steroid ) or topical anti-inflammatory drugs on target knee within 7 days prior to administration in the study
  6. With serious prior or ongoing medical conditions (e.g. concomitant illness such as cardiovascular (e.g. New York Heart Association grade III or IV), hepatic (e.g. Child-Pugh Class C), psychiatric condition, alcoholism, drug abuse), medical history, physical findings, , or laboratory abnormality that in the investigators' opinion could interfere with the results of the trial or adversely affect the safety of the patient
  7. With any evidence of malignant disease with life expectancy of less than 1 year
  8. Pregnant or lactating women or planning to be pregnant during the study period
  9. With body mass index (BMI) greater or equal to 35 kg/m2
  10. With joint diseases except knee osteoarthritis considered by investigator not eligible to enter the study
  11. With known history of human immunodeficiency virus (HIV) infection.
  12. Judged to be not applicable to this study by investigator such as difficulty of follow-up observation
  13. With any other serious diseases/medical history considered by the investigator not in the condition to enter the trial
  14. Having participated other investigational study within 4 weeks of entering this study
  15. With known history of claustrophobia
  16. Having any existing active/inactive implanted medical devices, such as cardiac pacemaker, cochlear, intracranial vascular clips or neurostimulator, etc...
  17. Having any existing metallic intraocular foreign body

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): NCT02784964


Locations
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Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan, 112
Chang Gung Memorial Hospital Linkou
Taoyuan City, Taiwan, 333
Sponsors and Collaborators
UnicoCell Biomed CO. LTD
A2 Healthcare Taiwan Corporation
Investigators
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Principal Investigator: Yu-Han Chang, MD Chang Gung Memorial Hospital
Principal Investigator: Cheng-Fong Chen, MD Taipei Veterans General Hospital, Taiwan

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Responsible Party: UnicoCell Biomed CO. LTD
ClinicalTrials.gov Identifier: NCT02784964     History of Changes
Other Study ID Numbers: CT21
First Posted: May 27, 2016    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases