Tennis ElbowPhase 1/2NCT02131077
Safety and Efficacy Study of Allogeneic Adipose-derived Stem Cells for Treatment of Lateral Epicondylitis
A Phase 1/2 study testing ALLO-ASC-TI in people with Tennis Elbow, run by Anterogen Co., Ltd. at 6 sites in South Korea.
Trial summary
The objective of this study is to evaluate the safety and efficacy of allogeneic adipose-derived stem cells (ALLO-ASC) in patients with lateral epicondylitis. Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Tennis Elbow
- What is being tested?
- ALLO-ASC-TI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 6 sitesSouth Korea
- Study dates
- Jan 2014to Aug 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 19 years.
- Patients who are diagnosed as lateral epicondylitis (Pain≥4 of VAS during activity).
- Patients who has sustained pain more than 6 months
- Patients who lasting for pain in spite of conservative therapy
- Patients who have one lesion under ultrasonic photography
- Negative for urine beta-HCG for women of childbearing age
- Patient who is able to give written informed consent prior to study start and to comply with the study requirements
Who cannot join
- Patients who has been experienced steroid and prolotherapy or other treatment within 3 months at screening time
- Patients who have lesion size of width and length more than 1 cm using ultrasonic photography test
- Patients who were accompanied by the disease as follows: A. Arthritis of related joint to the target lesion (ex, cubital osteo- arthritis), B.Synovitis of related joint to the target lesion, C.Entrapment of related nerve to the target lesion(ex, radial tunnel syndrome), D.Generalized pain syndrome, E.Radiculopathy related to the target lesion(ex, cervical spodylosis ,cervical radicular syndrome), F.Rheumatoid arthritis, G.Previous fracture of arm causing limitations in arm function, H.Impaired sensibility, I.Paralysis
- Patients who are pregnant or breast-feeding
- Patients who have allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue
- Patients who have history of fracture and dislocation at Ipsilateral upper extremity within 2 years recently
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- Patients who have operation history in tendon, ligament and bone at Ipsilateral upper extremity within 2 years recently
- Patients who are unwilling to use an "effective" method of contraception during the study
- Patients who have a clinically relevant history of abuse of alcohol or drugs
- Patients who are considered not suitable for the study by investigator
- Patients who have experienced treatment with stem cell before this study
- Patients who currently enrolled in another investigational drug study within 30 days of screening
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Asan Medical Center
Seoul
Chung-Ang University Hosptal
Seoul
Gangnam Severance Hospital
Seoul
Nanoori hospital
Seoul
Samsung medical center
Seoul
Seoul National University Hospital
Seoul
About this study
Official title: A Multi-center, Randomized, Placebo-controlled, Double-blind, Parallel-group, Phase I/II Clinical Study to Evaluate Safety and Efficacy of Allogeneic Adipose-derived Stem Cells for the Treatment of Lateral Epicondylitis
The objective of this study is to evaluate the safety and efficacy of allogeneic adipose-derived stem cells (ALLO-ASC) in patients with lateral epicondylitis.
- Conditions
- Tennis Elbow
- Being tested
- ALLO-ASC-TI, Placebo
- Keywords
- Lateral Epicondylitis
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALLO-ASC-TIBiological
Also called Allogenic adipose-derived stem cell
PlaceboDrug
Also called 0.9% Saline
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | ALLO-ASC-TI injection Receives: Biological: ALLO-ASC-TI |
| Placebo | Placebo comparator | Saline injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Improvement of VAS pain score at 12 weeks compared to baseline per each group
Measured: Week 12
Secondary outcomes (5)
VAS pain score
Changes in the VAS pain score during activity per each group
Measured: week 2, week 6 and week 12
Improvement rate of VAS pain score
Improvement rate of VAS pain score at rest per each group
Measured: week 2, week 6 and week 12
Modified Mayo Clinic Performance Index
Change in Modified Mayo Clinic Performance Index per each group
Measured: week 2, week 6 and week 12
Ultrasonic photography
Change in analysis of lesion size per each group
Measured: week 6 and week 12
Safety
Clinically measured abnormality of laboratory tests and adverse events
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startJan 2014
- Primary completionOct 2014
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tennis ElbowStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anterogen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- S G Chung, M.D., Ph.D, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131077
- Sponsor's protocol ID
- ALLO-ASC-TI-201
- Status last verified
- May 2014
- First submitted
- 29 Apr 2014
- Last updated
- 23 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Placebo-controlled, Double-blind, Parallel-group, Phase I/II Clinical Study to Evaluate Safety and Efficacy of Allogeneic Adipose-derived Stem Cells for the Treatment of Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT02131077
- Acronym / sponsor ID
- ALLO-ASC-TI-201
- Conditions
- Tennis Elbow
- Keywords
- Lateral Epicondylitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Anterogen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 6 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the safety and efficacy of allogeneic adipose-derived stem cells (ALLO-ASC) in patients with lateral epicondylitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Biological: ALLO-ASC-TIALLO-ASC-TI injection |
| Placebo | Placebo comparator | Drug: PlaceboSaline injection |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Older than 19 years.
- Patients who are diagnosed as lateral epicondylitis (Pain≥4 of VAS during activity).
- Patients who has sustained pain more than 6 months
- Patients who lasting for pain in spite of conservative therapy
- Patients who have one lesion under ultrasonic photography
Key exclusion criteria (12 listed)
- Patients who has been experienced steroid and prolotherapy or other treatment within 3 months at screening time
- Patients who have lesion size of width and length more than 1 cm using ultrasonic photography test
- Patients who were accompanied by the disease as follows: A. Arthritis of related joint to the target lesion (ex, cubital osteo- arthritis), B.Synovitis of related joint to the target lesion, C.Entrapment of related nerve to the target lesion(ex, radial tunnel syndrome), D.Generalized pain syndrome, E.Radiculopathy related to the target lesion(ex, cervical spodylosis ,cervical radicular syndrome), F.Rheumatoid arthritis, G.Previous fracture of arm causing limitations in arm function, H.Impaired sensibility, I.Paralysis
- Patients who are pregnant or breast-feeding
- Patients who have allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALLO-ASC-TIAlso: Allogenic adipose-derived stem cell | Biological | treatment |
| PlaceboAlso: 0.9% Saline | Drug | Placebo |
Primary outcome
Efficacy
Time frame: Week 12
Improvement of VAS pain score at 12 weeks compared to baseline per each group
5 secondary outcomes
VAS pain score
Time frame: week 2, week 6 and week 12
Improvement rate of VAS pain score
Time frame: week 2, week 6 and week 12
Modified Mayo Clinic Performance Index
Time frame: week 2, week 6 and week 12
Ultrasonic photography
Time frame: week 6 and week 12
Safety
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
S G Chung, M.D., Ph.D principal investigator
Seoul National University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ALLO-ASC-TI in people with Tennis Elbow, run by Anterogen Co., Ltd. at 6 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2016.