Safety and Efficacy Study of Allogeneic Adipose-derived Stem Cells for Treatment of Lateral Epicondylitis

Tennis Elbow Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02131077
• Other study ID #: ALLO-ASC-TI-201
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 29, 2014
• Last updated: November 22, 2016
• Start date: January 2014
• Est. completion date: August 2015

Study information

• Verified date: May 2014
• Source: Anterogen Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Older than 19 years.

2. Patients who are diagnosed as lateral epicondylitis (Pain=4 of VAS during activity).

3. Patients who has sustained pain more than 6 months

4. Patients who lasting for pain in spite of conservative therapy

5. Patients who have one lesion under ultrasonic photography

6. Negative for urine beta-HCG for women of childbearing age

7. Patient who is able to give written informed consent prior to study start and to comply with the study requirements

Exclusion Criteria:

1. Patients who has been experienced steroid and prolotherapy or other treatment within 3 months at screening time

2. Patients who have lesion size of width and length more than 1 cm using ultrasonic photography test

3. 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

4. Patients who are pregnant or breast-feeding

5. Patients who have allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue

6. Patients who have history of fracture and dislocation at Ipsilateral upper extremity within 2 years recently

7. Patients who have operation history in tendon, ligament and bone at Ipsilateral upper extremity within 2 years recently

8. Patients who are unwilling to use an "effective" method of contraception during the study

9. Patients who have a clinically relevant history of abuse of alcohol or drugs

10. Patients who are considered not suitable for the study by investigator

11. Patients who have experienced treatment with stem cell before this study

12. Patients who currently enrolled in another investigational drug study within 30 days of screening

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tennis Elbow

Intervention

Biological:
• ALLO-ASC-TI

Drug:
• Placebo

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Chung-Ang University Hosptal	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Nanoori hospital	Seoul
Korea, Republic of	Samsung medical center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Anterogen Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy	Improvement of VAS pain score at 12 weeks compared to baseline per each group	Week 12	No
Secondary	VAS pain score	Changes in the VAS pain score during activity per each group	week 2, week 6 and week 12	No
Secondary	Improvement rate of VAS pain score	Improvement rate of VAS pain score at rest per each group	week 2, week 6 and week 12	No
Secondary	Modified Mayo Clinic Performance Index	Change in Modified Mayo Clinic Performance Index per each group	week 2, week 6 and week 12	No
Secondary	Ultrasonic photography	Change in analysis of lesion size per each group	week 6 and week 12	Yes
Secondary	Safety	Clinically measured abnormality of laboratory tests and adverse events	Week 12	Yes