Adipose-derived Stem Cells (ADSCs) for Knee Osteoarthritis

NCT02784964 | Completed Phase 1 DMC

• 1 other identifier: CT21
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

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

  Weeks 0, 24

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

  Week 48

Secondary Outcomes (11)

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

  Weeks 0, 2, 4, 12, 24, 36, 48

• 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

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

  Weeks 0, 24, 48, 72, 96

• 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

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

  Week 0, 2, 4, 12, 24, 48, 96

Study Arms (4)

Elixcyte 8mL

EXPERIMENTAL

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

Biological: Elixcyte 8 ml

Hya Joint Plus

ACTIVE COMPARATOR

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

Device: Hya Joint Plus

Elixcyte 4mL

EXPERIMENTAL

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

Biological: Elixcyte 4 ml

Elixcyte 2mL

EXPERIMENTAL

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

Biological: Elixcyte 2 ml

Interventions

Elixcyte 8 ml BIOLOGICAL

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

Elixcyte 8mL

Hya Joint Plus DEVICE

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

Hya Joint Plus

Elixcyte 4 ml BIOLOGICAL

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

Elixcyte 4mL

Elixcyte 2 ml BIOLOGICAL

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

Elixcyte 2mL

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UnicoCell Biomed CO. LTD: lead
• A2 Healthcare Taiwan Corporation: collaborator

Study Sites (2)

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

Chang Gung Memorial Hospital Linkou

Taoyuan, 333, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 34717765 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Yu-Han Chang, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Cheng-Fong Chen, MD

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2016
• First Posted: May 27, 2016
• Study Start: March 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: June 1, 2021
• Last Updated: July 15, 2021

Record last verified: 2020-11

Locations

TW (2)