Adipose-derived Stem Cells (ADSCs) for Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02784964
• Other study ID #: CT21
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 2016
• Est. completion date: June 2021

Study information

• Verified date: November 2020
• Source: UnicoCell Biomed CO. LTD
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: June 2021
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• Elixcyte 8 ml
ADSC 6.4*10^7 cells, allogeneic injection

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

Biological:
• Elixcyte 4 ml
ADSC 3.2*10^7 cells, allogeneic injection
• Elixcyte 2 ml
ADSC 1.6*10^7 cells, allogeneic injection

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Chang Gung Memorial Hospital Linkou	Taoyuan City

Sponsors (2)

Lead Sponsor	Collaborator
UnicoCell Biomed CO. LTD	A2 Healthcare Taiwan Corporation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline to post-treatment visit of WOMAC pain score at week 24 after treatment		Weeks 0, 24
Primary	Incidence of adverse events (AEs) and serious adverse events (SAEs)		Week 48
Secondary	Changes from baseline to post-treatment visits of Visual Analogue Scale (VAS) to measure Pain Levels		Weeks 0, 2, 4, 12, 24, 36, 48
Secondary	Changes from baseline to post-treatment visits of scores of sections in Knee Society Clinical Rating System (KSCRS) Score		Weeks 0, 2, 4, 12, 24, 36, 48
Secondary	Changes from baseline to post-treatment visits of MRI examination results		Weeks 0, 24, 48, 72, 96
Secondary	Changes from baseline to post-treatment visits of total score, and sub-scores of all sections in WOMAC		Weeks 0, 2, 4, 12, 36, 48
Secondary	Total acetaminophen consumption amount during the first 48 weeks and week 48 to week 96		Week 0, 2, 4, 12, 24, 48, 96
Secondary	Total non-steroidal anti-inflammatory drug (NSAID) consumption amount during the first 48 weeks and week 48 to week 96		Weeks 0, 2, 4, 12, 24
Secondary	Time to subject first time consumes acetaminophen		Weeks 0, 2, 4, 12, 24
Secondary	Time to subject first time consumes non-steroidal anti-inflammatory drug (NSAID)		Weeks 0, 2, 4, 12, 24
Secondary	Number of patients with clinically abnormal laboratory values and/or adverse events that are related to treatment		Weeks 0, 2, 4, 12, 24, 36, 48, 72, 96
Secondary	Number of patients with clinically abnormal vital signs and/or adverse events that are related to treatment		Weeks 0, 2, 4, 12, 24, 36, 48, 72, 96
Secondary	Changes from baseline to week 96 visit in cartilage thickness in the total femorotibial joint by centralized (independent) imaging interpretation.		Weeks 0, 24, 48, 72, 96