Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000402448
Ethics application status
Approved
Date submitted
24/07/2007
Date registered
6/08/2007
Date last updated
22/09/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Autologous Tenocytes Therapy to Improve the Healing Process of Tennis Elbow – A Preliminary Clinical Trail
Scientific title
Autologous Tenocytes Therapy to Improve the Healing Process of Tennis Elbow
Secondary ID [1] 263093 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tennis elbow 2194 0
Tendinosis 2195 0
Condition category
Condition code
Musculoskeletal 2289 2289 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Autologous Tenocytes Injection
Autologous tenocytes will be digested from a small epitendineum tissue (connective tissue on the surface of tendon) harvested from patients’ patellar tendon. After a period of in vivo cultivation, 2ml of autologous tenocytes at concentration of 3X106cell/ml will be inject into the elbow site where feel most pain.Patients will be rescheduled for follow-up appointment at 4 and 12 weeks after the injection.
During any stage of this study, patients are obligation free to leave the experiment. Those chosen to leave will be referral to standard treatment.
Intervention code [1] 1910 0
Treatment: Other
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3180 0
Symptom relief
Timepoint [1] 3180 0
Patients will be asked to score their symptom before the treatment and 4 , 12 weeks after treatment.
Secondary outcome [1] 5304 0
Functional Rehabilitation and Restore the working ability
Timepoint [1] 5304 0
Patients will be subjected to three comprehensive assessment schemes( a. Quick DASH Score
b. Upper Extreme Functional Score
c. American Shoulder and Elbow Surgeon Scale
, before the treatment and 4 , 12 weeks after treatment.

Eligibility
Key inclusion criteria
1. History of tennis elbow longer than 6 months 2. Previously have received conservative treatment and not respond to the treatment.
Minimum age
30 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Received steroid inject within the last 3 months.2. Previously have surgery intervention for tennis elbow 3. Any bone-muscular systematic disease like rheumatic disease, systemic lupus erythematous, ankylosing spondylosis.4. Any history of mental and psychological illness.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
15/08/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2453 0
Commercial sector/Industry
Name [1] 2453 0
Orthocell Pty Ltd
Country [1] 2453 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Orthocell Pty Ltd
Address
Building 191 Murdoch University, South Street, Murdoch, Western Australia 6150
Country
Australia
Secondary sponsor category [1] 2225 0
None
Name [1] 2225 0
Nil
Address [1] 2225 0
Country [1] 2225 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4316 0
Sir Charles Gairdner Hospital Human Research Ethics Committee
Ethics committee address [1] 4316 0
Ethics committee country [1] 4316 0
Australia
Date submitted for ethics approval [1] 4316 0
Approval date [1] 4316 0
13/05/2008
Ethics approval number [1] 4316 0
2007-116

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27724 0
Address 27724 0
Country 27724 0
Phone 27724 0
Fax 27724 0
Email 27724 0
Contact person for public queries
Name 11099 0
Prof. David Wood
Address 11099 0
M508 Centre for Orthopaedic Research
QEII Medical Centre
Level 2 M Block
Nedlands WA 6009
Country 11099 0
Australia
Phone 11099 0
61-8-9346 3213
Fax 11099 0
61-8-9346 3210
Email 11099 0
[email protected]
Contact person for scientific queries
Name 2027 0
Prof. Minghao Zheng
Address 2027 0
M508 Centre for Orthopaedic Research
QEII Medical Centre
Level 2 M Block
Nedlands WA 6009
Country 2027 0
Australia
Phone 2027 0
61-8-9346 3213
Fax 2027 0
61-8-9346 3210
Email 2027 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseBio-Enhanced Neoligaments Graft Bearing FE002 Primary Progenitor Tenocytes: Allogeneic Tissue Engineering & Surgical Proofs-of-Concept for Hand Ligament Regenerative Medicine.2023https://dx.doi.org/10.3390/pharmaceutics15071873
N.B. These documents automatically identified may not have been verified by the study sponsor.