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Mesenchymal Stem Cell Treatment for Primary Osteoarthritis Knee

Primary Purpose

Osteoarthritis Knee

Status
Completed
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
Adipose-Derived Mesenchymal Stem Cells
Sponsored by
Steminent Biotherapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis Knee

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ADMSCs

Arm Description

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

Outcomes

Primary Outcome Measures

Safety of intra-articular injection of autologous ADMSCs by incidence of adverse events and alterations in vital signs, blood chemistry profiles, complete blood count, urinalysis, and also the physical examination of the knees.

Secondary Outcome Measures

Clinical assessment of visual analogue scale (VAS)
Clinical assessment of Short Form 36 questionnaire (SF-36)
Clinical assessment of Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Clinical assessment of Hospital for Special Surgery (HSS) Knee Score
Clinical imaging assessment of knee X-ray
Clinical imaging assessment of MRI of the knee

Full Information

First Posted
September 4, 2015
Last Updated
October 26, 2022
Sponsor
Steminent Biotherapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02544802
Brief Title
Mesenchymal Stem Cell Treatment for Primary Osteoarthritis Knee
Official Title
Treatment of Primary Osteoarthritis of the Knee Joint With Autologous Mesenchymal Stem Cells
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Steminent Biotherapeutics Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ADMSCs
Arm Type
Experimental
Arm Description
Three intra-articular injections of ADMSCs at the dose of 8~10x10^6 cells/injection
Intervention Type
Drug
Intervention Name(s)
Adipose-Derived Mesenchymal Stem Cells
Primary Outcome Measure Information:
Title
Safety of intra-articular injection of autologous ADMSCs by incidence of adverse events and alterations in vital signs, blood chemistry profiles, complete blood count, urinalysis, and also the physical examination of the knees.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Clinical assessment of visual analogue scale (VAS)
Time Frame
12 months
Title
Clinical assessment of Short Form 36 questionnaire (SF-36)
Time Frame
12 months
Title
Clinical assessment of Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time Frame
12 months
Title
Clinical assessment of Hospital for Special Surgery (HSS) Knee Score
Time Frame
12 months
Title
Clinical imaging assessment of knee X-ray
Time Frame
12 months
Title
Clinical imaging assessment of MRI of the knee
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject has bilateral Kellgren and Lawrence grade II-III primary osteoarthritis as determined by X-ray. Subject's pain score is 8-13 points (Lequesne's index). Ages between 50-70 years. Signed informed consent from the subject. Female subjects should be post-menopausal women Exclusion Criteria: Subject infected with hepatitis B, hepatitis C, HIV, syphilis or HTLV. Subject not suitable for liposuction surgery. Subject with hypersensitivity/allergy to anesthetic. Subject's creatinine values higher than 1.6mg/dl. Subject with body mass index, BMI over 30. Subject's studied knee treated with intra-articular injection therapy within 6 months prior to screen. Subject has undergone surgery on either side of knee, including fracture surgery, arthroscopic surgery, meniscus repair surgery, or cruciate ligament reconstruction surgery. Subject enrolled in any other cell therapy studies within the past 30 days. Subject who the investigator considers inappropriate for the clinical trial due to any other reasons than those listed above. Subject has a history of gouty arthritis, septic arthritis, rheumatoid arthritis and any other autoimmune arthritis of the knee joint. Subject has had major medical problems in vital organs, such as; heart, liver, kidney, or lung.
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

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Mesenchymal Stem Cell Treatment for Primary Osteoarthritis Knee

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