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Adipose-derived Stem Cells (ADSCs) for Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status

Completed

Phase

Phase 1

Locations

Taiwan

Study Type

Interventional

Intervention

Elixcyte 8 ml

Hya Joint Plus

Elixcyte 4 ml

Elixcyte 2 ml

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Aged 40-80 years (inclusive)
Kellgren-Lawrence grading I-III, as determined by American College of Rheumatology (ACR) criteria for osteoarthritis of the knee
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
Having provided informed consent

Exclusion Criteria:

With previous surgery of articular fracture, ligament reconstruction, meniscal reconstruction, and knee arthroplasty on the target knee joint
With previous intra-articular intervention on the target knee joint within past 3 months (e.g. steroid, anaesthetic, sodium hyaluronate)
Known or suspected infection of the target knee joint
Ascertained hypersensitivity to any component used in the study
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
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
With any evidence of malignant disease with life expectancy of less than 1 year
Pregnant or lactating women or planning to be pregnant during the study period
With body mass index (BMI) greater or equal to 35 kg/m2
With joint diseases except knee osteoarthritis considered by investigator not eligible to enter the study
With known history of human immunodeficiency virus (HIV) infection.
Judged to be not applicable to this study by investigator such as difficulty of follow-up observation
With any other serious diseases/medical history considered by the investigator not in the condition to enter the trial
Having participated other investigational study within 4 weeks of entering this study
With known history of claustrophobia
Having any existing active/inactive implanted medical devices, such as cardiac pacemaker, cochlear, intracranial vascular clips or neurostimulator, etc...
Having any existing metallic intraocular foreign body

Sites / Locations

Taipei Veterans General Hospital
Chang Gung Memorial Hospital Linkou

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Elixcyte 8mL

Hya Joint Plus

Elixcyte 4mL

Elixcyte 2mL

Arm Description

ADSC 6.4*10^7 cells, allogeneic injection, one time injection on Day 1

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

ADSC 3.2*10^7 cells, allogeneic injection, one time injection on Day 1

ADSC 1.6*10^7 cells, allogeneic injection, one time injection on Day 1

Outcomes

Primary Outcome Measures

Changes from baseline to post-treatment visit of WOMAC pain score at week 24 after treatment

Incidence of adverse events (AEs) and serious adverse events (SAEs)

Secondary Outcome Measures

Changes from baseline to post-treatment visits of Visual Analogue Scale (VAS) to measure Pain Levels

Changes from baseline to post-treatment visits of scores of sections in Knee Society Clinical Rating System (KSCRS) Score

Changes from baseline to post-treatment visits of MRI examination results

Changes from baseline to post-treatment visits of total score, and sub-scores of all sections in WOMAC

Total acetaminophen consumption amount during the first 48 weeks and week 48 to week 96

Total non-steroidal anti-inflammatory drug (NSAID) consumption amount during the first 48 weeks and week 48 to week 96

Time to subject first time consumes acetaminophen

Time to subject first time consumes non-steroidal anti-inflammatory drug (NSAID)

Number of patients with clinically abnormal laboratory values and/or adverse events that are related to treatment

Number of patients with clinically abnormal vital signs and/or adverse events that are related to treatment

Changes from baseline to week 96 visit in cartilage thickness in the total femorotibial joint by centralized (independent) imaging interpretation.

Full Information

NCT ID

NCT02784964

First Posted

May 16, 2016

Last Updated

July 14, 2021

Sponsor

UnicoCell Biomed CO. LTD

Collaborators

A2 Healthcare Taiwan Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02784964

Brief Title

Adipose-derived Stem Cells (ADSCs) for Knee Osteoarthritis

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

March 2016 (Actual)

Primary Completion Date

July 2018 (Actual)

Study Completion Date

June 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UnicoCell Biomed CO. LTD

Collaborators

A2 Healthcare Taiwan Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To assess the safety of allogeneic injection of expanded ADSCs to patients with knee osteoarthritis To assess the efficacy of allogeneic injection of expanded ADSCs to patients with knee osteoarthritis

6. Conditions and Keywords

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

Knee Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

57 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Elixcyte 8mL

Arm Type

Experimental

Arm Description

ADSC 6.4*10^7 cells, allogeneic injection, one time injection on Day 1

Arm Title

Hya Joint Plus

Arm Type

Active Comparator

Arm Description

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

Arm Title

Elixcyte 4mL

Arm Type

Experimental

Arm Description

ADSC 3.2*10^7 cells, allogeneic injection, one time injection on Day 1

Arm Title

Elixcyte 2mL

Arm Type

Experimental

Arm Description

ADSC 1.6*10^7 cells, allogeneic injection, one time injection on Day 1

Intervention Type

Biological

Intervention Name(s)

Elixcyte 8 ml

Intervention Description

ADSC 6.4*10^7 cells, allogeneic injection

Intervention Type

Device

Intervention Name(s)

Hya Joint Plus

Intervention Description

Hya Joint Plus synovial fluid supplement 3mL, SciVision Biotech Inc.

Intervention Type

Biological

Intervention Name(s)

Elixcyte 4 ml

Intervention Description

ADSC 3.2*10^7 cells, allogeneic injection

Intervention Type

Biological

Intervention Name(s)

Elixcyte 2 ml

Intervention Description

ADSC 1.6*10^7 cells, allogeneic injection

Primary Outcome Measure Information:

Title

Changes from baseline to post-treatment visit of WOMAC pain score at week 24 after treatment

Time Frame

Weeks 0, 24

Title

Incidence of adverse events (AEs) and serious adverse events (SAEs)

Time Frame

Week 48

Secondary Outcome Measure Information:

Title

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

Title

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

Title

Changes from baseline to post-treatment visits of MRI examination results

Time Frame

Weeks 0, 24, 48, 72, 96

Title

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

Title

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

Title

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

Title

Time to subject first time consumes acetaminophen

Time Frame

Weeks 0, 2, 4, 12, 24

Title

Time to subject first time consumes non-steroidal anti-inflammatory drug (NSAID)

Time Frame

Weeks 0, 2, 4, 12, 24

Title

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

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Aged 40-80 years (inclusive) Kellgren-Lawrence grading I-III, as determined by American College of Rheumatology (ACR) criteria for osteoarthritis of the knee 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 Having provided informed consent Exclusion Criteria: With previous surgery of articular fracture, ligament reconstruction, meniscal reconstruction, and knee arthroplasty on the target knee joint With previous intra-articular intervention on the target knee joint within past 3 months (e.g. steroid, anaesthetic, sodium hyaluronate) Known or suspected infection of the target knee joint Ascertained hypersensitivity to any component used in the study 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 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 With any evidence of malignant disease with life expectancy of less than 1 year Pregnant or lactating women or planning to be pregnant during the study period With body mass index (BMI) greater or equal to 35 kg/m2 With joint diseases except knee osteoarthritis considered by investigator not eligible to enter the study With known history of human immunodeficiency virus (HIV) infection. Judged to be not applicable to this study by investigator such as difficulty of follow-up observation With any other serious diseases/medical history considered by the investigator not in the condition to enter the trial Having participated other investigational study within 4 weeks of entering this study With known history of claustrophobia Having any existing active/inactive implanted medical devices, such as cardiac pacemaker, cochlear, intracranial vascular clips or neurostimulator, etc... Having any existing metallic intraocular foreign body

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yu-Han Chang, MD

Organizational Affiliation

Chang Gung Memorial Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Cheng-Fong Chen, MD

Organizational Affiliation

Taipei Veterans General Hospital, Taiwan

Official's Role

Principal Investigator

Facility Information:

Facility Name

Taipei Veterans General Hospital

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Facility Name

Chang Gung Memorial Hospital Linkou

City

Taoyuan City

ZIP/Postal Code

333

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

34717765

Citation

Chen CF, Hu CC, Wu CT, Wu HH, Chang CS, Hung YP, Tsai CC, Chang Y. Treatment of knee osteoarthritis with intra-articular injection of allogeneic adipose-derived stem cells (ADSCs) ELIXCYTE(R): a phase I/II, randomized, active-control, single-blind, multiple-center clinical trial. Stem Cell Res Ther. 2021 Oct 30;12(1):562. doi: 10.1186/s13287-021-02631-z.

Results Reference

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Adipose-derived Stem Cells (ADSCs) for Knee Osteoarthritis

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