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Trial History Detail on 2015-07-16

CUHK_CCT00433

2014-09-11

Prospective

CREC 2014.291-T

The Chinese University of Hong Kong

Dr. WL Tse

Dr. PC Ho

JoJo Kwok

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

26326553

jojokwok@cuhk.edu.hk

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

Dr WL Tse

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

26322065

tse@ort.cuhk.edu.hk

Department of Orthopaedics and Traumatoloy, Prince of Wales Hospital

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

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

臨床試驗研究 –「自體間質幹細胞治療腕關節軟骨缺損」

A pilot “SCIATICA” study

HKSAR

Yes

2014-08-05

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

Other

Autologous mesenchymal stem cell intra-articular injection

Autologous mesenchymal stem cell

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

Autologous mesenchymal stem cell intra-articular injection

-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

-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

18

75

Both Male and Female

Interventional

Non-randomized

Uncontrolled

Not Applicable

Single group

2014-10-01

20

Recruiting

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

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

No

2015-07-16

ChiCTR-OPC-14005353 

2014-10-20


Yes

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