Trial | NCT02784964  Report issue

Title

Adipose-derived Stem Cells (ADSCs) for Knee Osteoarthritis
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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    57
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
Study Started
Mar 31
2016
Primary Completion
Jul 31
2018
Study Completion
Jun 30
2021
Last Update
Jul 15
2021

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

Biological Elixcyte 2 ml

ADSC 1.6*10^7 cells, allogeneic injection

Elixcyte 8mL Experimental

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

Hya Joint Plus Active Comparator

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

Elixcyte 4mL Experimental

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

Elixcyte 2mL Experimental

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

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
No Results Posted