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Trial History Detail on 2016-04-05

CUHK_CCT00469

2015-08-20

Prospective

2014.279-T

The Chinese University of Hong Kong

Prof. Kevin HO Ki Wai

Prof. G. Li

Jenny ZHANG Jing

Department of Orthopaedics and Traumatology, Prince of Wales Hospital, Shatin, Hong Kong

26326553

jennyzhang1009@cuhk.edu.hk

Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong

Prof. Kevin HO Ki Wai

Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong

26322715

kevinho@cuhk.edu.hk

Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong

A Randomized Control Clinical Trial to Evaluate the Efficacy of Intra-articular Injections of Mesenchymal Stem Cells versus Hyaluronic Acid in Patients Affected by Osteoarthritis of the Knee

RCT mesenchymal stem cells versus hyaluronic acid in OA knee

比較膝關節内注射間充質幹細胞及透明質酸用於治療膝關節炎的效用

RCT mesenchymal stem cells versus hyaluronic acid in OA knee

HKSAR

Yes

2015-06-17

Degenerative osteoarthritis of the knee

Drug

autologous bone marrow derived mesenchymal stem cells and hyaluronic acid

during the operation

To compare the effect of mesenchymal stem cells and hyaluronic acid on treating osteoarthritis of the knee, after intra-articular injection of both

Patients must comply with all the following criteria in order to be included in the study

1.Male and female subjects aged between 18 and < 65;
2.All patients must provide their written consent;
3.All patients must be affected by primary osteoarthritis of the knee (according to ACR – American College of Rheumatology – classification); In case a patient shows a bilateral OA, it will be included and treated for both knees;
4.All patients must have pain symptoms since at least 2 months;
5. All patients must experience, during the inclusion visit (T0), a pain level higher than or equal to 5.0 cm on a VAS scale of 10 cm;
6.All patients should have at least 8 years of school education;
7.Radiological evidence of osteoarthritis with Kellgren and Lawrence grade 2 and 3

The presence of one or more of the following criteria will exclude the patient from the study:

1.Patients with previous cases of alcoholism or drug abuse;
2.Pregnancy and breast-feeding;
3.Presence of serious pathologies;
4.Hypersensitivity towards hyaluronic acid;
5.Intra-articular infiltrations of hyaluronic acid or steroids that are in the process of being administered or that have been interrupted since less than 3 months;
6.Steroid-based systemic therapy in progress or interrupted since less than 1 month and/or anti-clotting drugs;
7.History of fractures and/or severe traumas of the knee bone;
8.Significant hematologic diseases;
9.Non-consenting patients who have not provided the written Informed Consent;
10.Mechanical instability, ligamentous laxity/deficiency and gross deformity;
11.Isolated meniscal tear without evident of osteoarthritis.

18

65

Both Male and Female

Interventional

Randomized

Placebo

Single-blind

Parallel

2015-12-01

30

Not Yet Recruiting

Functional osteoarthritis scores including WOMAC,KSS and KSFS, SF-36 and VAS pain scores will be assessed at 2 weeks, 3 months, 6 months, 9 months and 12 months post-operation;
Radiologic knee osteoarthritis will be assessed by MRI-and X-ray before operation, 3 months and 12 months post-operation;
Adverse event will be monitored during the study.

Analgesic/NSAIDs consumption;
Crackling sounds with movement (subjective evaluation);
Per-articular swelling (thigh and knee circumference evaluation).

No

2020-05-14

ChiCTR-IOR-15006942

2015-08-20

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