Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00433

2 Trial Registration Date

2014-09-11

i Registration Status

Prospective

3 Secondary IDs

CREC 2014.291-T

4 Source(s) of Funding

The Chinese University of Hong Kong

5 Primary Sponsor

Dr. WL Tse

6 Secondary Sponsor

Dr. PC Ho

Function

Please specify

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

i Name

JoJo Kwok

ii Address

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

iii Phone

26326553

iv Email

jojokwok@cuhk.edu.hk

v Affiliation

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

vi Country

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

i Name

Dr WL Tse

ii Address

Department of Orthopaedics and Traumatoloy, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, NT Hong Kong, SAR

iii Phone

26322065

iv Email

tse@ort.cuhk.edu.hk

v Affiliation

Department of Orthopaedics and Traumatoloy, Prince of Wales Hospital

vi Country

9 Official Scientific Title of the Study

A pilot “SCIATICA” study - Stem Cell Intra-Articular Therapeutic Injection for Carpal Affections

10 Public Title

A pilot “SCIATICA” study - Stem Cell Intra-Articular Therapeutic Injection for Carpal Affections

i Public Title in Chinese 研究名稱

臨床試驗研究 –「自體間質幹細胞治療腕關節軟骨缺損」

11 Short Title (Optional)

A pilot “SCIATICA” study

12 Countries of Recruitment

HKSAR

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2014-08-05

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Patients with post-traumatic chronic wrist pain, with imaging and previous arthroscopic evidence of wrist carpal bone chondral defects who opt for active treatment

15 Intervention

i Types of intervention

Other

Please specify

Autologous mesenchymal stem cell intra-articular injection

ii Description/ name of Intervention/article

Autologous mesenchymal stem cell

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Therapeutic wrist arthroscopy and bone marrow aspiration will be performed. Therapeutic wrist arthro

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Autologous mesenchymal stem cell intra-articular injection

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

-Wrist pain of mechanical origin(post-traumatic)
-The pain cannot be relieved by treating other underlying defects other than carpal affections
-Patients with imaging and previous arthroscopic evidence of wrist carpal bone chondral defects
-Absence of any local or general infection
-Hematologic and biochemical analyses with no significant alterations that contraindicate intervention
-Patient who is able to understand the nature the study and provide informed written consent

ii Exclusion Criteria

-Age > 75 or <18 years old or legally dependent
-Patients with past history of hematologic disorders
-Signs of infection or positive serology for HIV, HBV, HCV, or syphilis
-Congenital or acquired diseases leading to significant wrist deformities that may interfere with cell application or interpretation of results
-Pregnancy or breast-feeding
-Neoplasia
-Immunosuppression
-Participation in another clinical trial or treatment with another investigational product within 30 days before inclusion in the study
-Patients with alcoholism/drug abuse
-Other medical conditions that may discourage participation in the study

iii Age Minimum

18

iv Age Maximum

75

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Uncontrolled

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Single group

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-10-01

21 Target Sample Size

20

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Diagnostic radiological (MRI)assessments will be done at post-injection 6th month.

24 Secondary Outcome

VAS, functional wrist score, PRWE, DASH, Power, ROM at post-injection 3rd, 6th, 12nd and 24th month

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-07-16

27 Primary Registry and Trial Identifying Number

ChiCTR-OPC-14005353

28 Date of Registration in Primary Registry

2014-10-20

* Legacy Fields

i Recruitment Information Available?

No

ii Link to Recruitment Information

N/A

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Trial History Detail on 2014-11-21