Adipose-derived Stem Cells (ADSCs) for Knee Osteoarthritis

NCT ID: NCT02784964

Last Updated: 2021-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2021-06-30

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

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Elixcyte 8mL

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

Group Type: EXPERIMENTAL

Elixcyte 8 ml

Intervention Type: BIOLOGICAL

ADSC 6.4\*10\^7 cells, allogeneic injection

Hya Joint Plus

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

Group Type: ACTIVE_COMPARATOR

Hya Joint Plus

Intervention Type: DEVICE

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

Elixcyte 4mL

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

Group Type: EXPERIMENTAL

Elixcyte 4 ml

Intervention Type: BIOLOGICAL

ADSC 3.2\*10\^7 cells, allogeneic injection

Elixcyte 2mL

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

Group Type: EXPERIMENTAL

Elixcyte 2 ml

Intervention Type: BIOLOGICAL

ADSC 1.6\*10\^7 cells, allogeneic injection

Interventions

Elixcyte 8 ml

ADSC 6.4\*10\^7 cells, allogeneic injection

Intervention Type: BIOLOGICAL

Hya Joint Plus

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

Intervention Type: DEVICE

Elixcyte 4 ml

ADSC 3.2\*10\^7 cells, allogeneic injection

Intervention Type: BIOLOGICAL

Elixcyte 2 ml

ADSC 1.6\*10\^7 cells, allogeneic injection

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

A2 Healthcare Taiwan Corporation

INDUSTRY

Sponsor Role: collaborator

UnicoCell Biomed CO. LTD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yu-Han Chang, MD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Cheng-Fong Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Locations

Taipei Veterans General Hospital

Taipei, , Taiwan

Chang Gung Memorial Hospital Linkou

Taoyuan, , Taiwan

Countries

Taiwan

References

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.

Reference Type: DERIVED

PMID: 34717765 (View on PubMed)

Other Identifiers

CT21

Identifier Type: -

Identifier Source: org_study_id