Clinical trial NCT02855073: Clinical Trial to Compare ReJoinTM to Sodium Hyaluronate Injection for Knee Osteoarthritis Cartilage Defects
Official title: A Randomized, Single-blind, Phase II Clinical Trial to Compare ReJoinTM (Autologous Adipose-derived Mesenchymal Progenitor Cells)to Sodium Hyaluronate Injection for the Patients With Knee Osteoarthritis Cartilage Defects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Defect of Articular Cartilage
Knee Osteoarthritis
Keywords: adipose-derived mesenchymal progenitor cells
Artz
Lead sponsor: Shanghai AbelZeta Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
First posted: 2016-08-04
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of ReJoinTM for the Knee Osteoarthritis patients with Cartilage Defects comparing to Sodium Hyaluronate Injection.

Detailed description: This is a randomized, single-blind,phase II clinical trial.

At least 28 subjects who are with a clinical diagnosis of knee osteoarthritis cartilage defects will be randomly distributed 1:1 to the treatment group or the control group after signing the ICF and screening tests.The treatment will accept ReJoinTM at the first and fourth week,and Sodium Hyaluronate Injection at the second and third week.The control group will accept Sodium Hyaluronate Injection weekly ,and four injections in total.The duration of the therapy is 48 weeks.

In addition, external control will be added if necessary.

Eligibility criteria: Inclusion Criteria:

* 18-70 years old, KOA couse ≤ 10 years
* Kellgren-Lawrence Ⅰ-Ⅲ
* VAS core \>6， more than 4 months
* Signed informed consent from the subject
* cartilage defect 2-6cm2

Exclusion Criteria:

* Pregnancy test positive.
* Subject infected with hepatitis C, HIV or syphilis.
* Subject enrolled in any other cell therapy studies within the past 30 days.
* Subject deemed to be not suitable for the study by the investigator

Primary outcomes:
measure: WOMAC scores
timeFrame: 48 weeks
Secondary outcomes:
measure: VAS scores
timeFrame: 0 day、8 weeks、24 weeks、36 weeks and 48 weeks
measure: SF-36 scores
timeFrame: 0 day、8 weeks、24 weeks、 36 weeks and 48 weeks
measure: Outbridge scoring
timeFrame: 1 day and 24 weeks
measure: CRP
timeFrame: 0 day、8 weeks、24 weeks、 36 weeks and 48 weeks
measure: Cartilage defect size
timeFrame: 0 day and 24 weeks
measure: Cartilage volume
timeFrame: 0 day and 24 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai ninth people's hospital
state: Shanghai
Study officials:
affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: You Wang
role: STUDY_DIRECTOR
References:
citation: Qiao Z, Tang J, Yue B, Wang J, Zhang J, Xuan L, Dai C, Li S, Li M, Xu C, Dai K, Wang Y. Human adipose-derived mesenchymal progenitor cells plus microfracture and hyaluronic acid for cartilage repair: a Phase IIa trial. Regen Med. 2020 Jan;15(1):1193-1214. doi: 10.2217/rme-2019-0068. Epub 2020 Feb 11.