Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00469

2 Trial Registration Date

2015-08-20

i Registration Status

Prospective

3 Secondary IDs

2014.279-T

4 Source(s) of Funding

The Chinese University of Hong Kong

5 Primary Sponsor

Prof. Kevin HO Ki Wai

6 Secondary Sponsor

Prof. G. Li

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Jenny ZHANG Jing

ii Address

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

iii Phone

26326553

iv Email

jennyzhang1009@cuhk.edu.hk

v Affiliation

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

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Prof. Kevin HO Ki Wai

ii Address

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

iii Phone

26322715

iv Email

kevinho@cuhk.edu.hk

v Affiliation

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

vi Country

9 Official Scientific Title of the Study

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

10 Public Title

RCT mesenchymal stem cells versus hyaluronic acid in OA knee

i Public Title in Chinese 研究名稱

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

11 Short Title (Optional)

RCT mesenchymal stem cells versus hyaluronic acid in OA knee

12 Countries of Recruitment

HKSAR

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2015-06-17

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Degenerative osteoarthritis of the knee

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

autologous bone marrow derived mesenchymal stem cells and hyaluronic acid

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

during the operation

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

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

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

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

ii Exclusion Criteria

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.

iii Age Minimum

18

iv Age Maximum

65

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2015-12-01

21 Target Sample Size

30

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

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.

24 Secondary Outcome

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

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2020-05-14

27 Primary Registry and Trial Identifying Number

ChiCTR-IOR-15006942

28 Date of Registration in Primary Registry

2015-08-20

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Trial History Detail on 2016-04-05