Mesenchymal Stem Cell Treatment for Primary Osteoarthritis Knee

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2019-01-31

Brief Summary

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The purpose of this study is to evaluate the safety and preliminary efficacy of autologous adipose-derived mesenchymal stem cells (ADMSCs) treatment for patients with primary osteoarthritis knee. Three intra-articular injections of autologous ADMSCs will be performed to subjects at a weekly interval.

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Detailed Description

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Conditions

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Osteoarthritis Knee

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ADMSCs

Three intra-articular injections of ADMSCs at the dose of 8\~10x10\^6 cells/injection

Group Type EXPERIMENTAL

Adipose-Derived Mesenchymal Stem Cells

Intervention Type DRUG

Interventions

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Adipose-Derived Mesenchymal Stem Cells

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Subject has bilateral Kellgren and Lawrence grade II-III primary osteoarthritis as determined by X-ray.
2. Subject's pain score is 8-13 points (Lequesne's index).
3. Ages between 50-70 years.
4. Signed informed consent from the subject.
5. Female subjects should be post-menopausal women

Exclusion Criteria

1. Subject infected with hepatitis B, hepatitis C, HIV, syphilis or HTLV.
2. Subject not suitable for liposuction surgery.
3. Subject with hypersensitivity/allergy to anesthetic.
4. Subject's creatinine values higher than 1.6mg/dl.
5. Subject with body mass index, BMI over 30.
6. Subject's studied knee treated with intra-articular injection therapy within 6 months prior to screen.
7. Subject has undergone surgery on either side of knee, including fracture surgery, arthroscopic surgery, meniscus repair surgery, or cruciate ligament reconstruction surgery.
8. Subject enrolled in any other cell therapy studies within the past 30 days.
9. Subject who the investigator considers inappropriate for the clinical trial due to any other reasons than those listed above.
10. Subject has a history of gouty arthritis, septic arthritis, rheumatoid arthritis and any other autoimmune arthritis of the knee joint.
11. Subject has had major medical problems in vital organs, such as; heart, liver, kidney, or lung.

Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No