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Treatment of Knee Osteoarthritis With Autologous Mesenchymal Stromal Cell Product (RegStem)

Primary Purpose

Osteoarthritis,Knee

Status
Completed
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
RegStem
Sponsored by
EMO Biomedicine Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis,Knee

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subjects who understand and sign the informed consent form for this study
  2. Grade 2~3 osteoarthritis according to the Kellgren-Lawrence grading scale with one-month X-ray
  3. Age is 50~75 years old
  4. Postmenopausal women
  5. VAS scores in 50 to 90 mm

Exclusion Criteria:

  1. Abnormal of liver and kidney: GOT and GPT > 100 IU/L, BUN >22 mg/dl and creatinine > 1.2 mg/dl.
  2. Positive serology for HIV, HTLV-1/2 and syphilis
  3. Women who are pregnant or breast feeding
  4. Serious pre-existing medical conditions: coagulation disorders, cardiovascular diseases (arrhythmias, myocardial infarction and surgery), renal diseases (chronic renal failure), liver diseases (cirrhosis), diabetes mellitus type I, cancer history.
  5. Other joint diseases: knee deformity (knee varus greater than 10 degree or valgus greater than 20 degree), rheumatic arthritis, gouty arthritis, septic arthritis, serious meniscal tear, other autoimmune arthritis.
  6. Skin inflammatory of knee
  7. Knee pain caused by referred pain from spine disease or hip joint disease. Knee pain combined with pain from spine disease or hip disease.
  8. Immunosuppressive state
  9. Subjects who were injected with hyaluronic acid and PRP in the past 6 months
  10. Body mass index (BMI) greater than 30
  11. Have a history of allergic reaction of any medication
  12. Participation in another clinical trial or treatment within 3 months
  13. Other pathologic conditions or circumstances that difficult participation in this study according to PI's evaluations

Sites / Locations

  • Far Eastern Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RegStem

Arm Description

Autologous MSC, 5×10^7 cells, one injection

Outcomes

Primary Outcome Measures

Safety of RegStem by incidence of adverse events and changes in physical examinations, vital signs and the results of clinical lab tests.
Clinical assessment of International Knee Documentation Committee (IKDC) score
Assess symptoms of knee, sport activity and function of knee

Secondary Outcome Measures

Clinical assessment of Knee injury and Osteoarthritis Outcome Score (KOOS)
Clinical assessment of visual analogue scale (VAS)
Clinical assessment of knee X-ray
Clinical assessment of knee MRI

Full Information

First Posted
December 21, 2016
Last Updated
November 10, 2019
Sponsor
EMO Biomedicine Corporation
Collaborators
Far Eastern Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03007576
Brief Title
Treatment of Knee Osteoarthritis With Autologous Mesenchymal Stromal Cell Product (RegStem)
Official Title
Phase I Clinical Trial - Treatment of Knee Osteoarthritis With Autologous Mesenchymal Stromal Cell Product (RegStem)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
August 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMO Biomedicine Corporation
Collaborators
Far Eastern Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Osteoarthritis (OA) is a common and incurable disease for the elderly in Taiwan, so it is an important mission to develop a new treatment for OA. Recently, cellular therapy is a new and popular medical treatment around the world, one of them is "Mesenchymal Stromal Cells (MSCs)". MSCs are found in many tissues of human body and play an important role for repairing, regeneration, anti-inflammatory and chondrogenesis. So, MSC product, RegStem, for osteoarthritis treatment becomes a developing target for new generation drugs. This study is to isolate and expand MSCs(RegStem) from infrapatellar fat pad of subject. When the number of MSCs expands to 1×10^8, cell will be cryopreserved in the liquid nitrogen tank until all release tests passed. On the distribution day, cell will be thawed and injected into joint cavity of patient (5×10^7). Subjects will be monitored after MSC product infusion of seven days, one month, six months and one year. The monitoring items include the changes of knee (by appearance, X-ray and MRI of knee) and pain improvement (by questionnaire).

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
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RegStem
Arm Type
Experimental
Arm Description
Autologous MSC, 5×10^7 cells, one injection
Intervention Type
Biological
Intervention Name(s)
RegStem
Other Intervention Name(s)
MSC
Intervention Description
RegStem, 1.5 ml, one injection
Primary Outcome Measure Information:
Title
Safety of RegStem by incidence of adverse events and changes in physical examinations, vital signs and the results of clinical lab tests.
Time Frame
48 weeks
Title
Clinical assessment of International Knee Documentation Committee (IKDC) score
Description
Assess symptoms of knee, sport activity and function of knee
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Clinical assessment of Knee injury and Osteoarthritis Outcome Score (KOOS)
Time Frame
48 weeks
Title
Clinical assessment of visual analogue scale (VAS)
Time Frame
48 weeks
Title
Clinical assessment of knee X-ray
Time Frame
48 weeks
Title
Clinical assessment of knee MRI
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who understand and sign the informed consent form for this study Grade 2~3 osteoarthritis according to the Kellgren-Lawrence grading scale with one-month X-ray Age is 50~75 years old Postmenopausal women VAS scores in 50 to 90 mm Exclusion Criteria: Abnormal of liver and kidney: GOT and GPT > 100 IU/L, BUN >22 mg/dl and creatinine > 1.2 mg/dl. Positive serology for HIV, HTLV-1/2 and syphilis Women who are pregnant or breast feeding Serious pre-existing medical conditions: coagulation disorders, cardiovascular diseases (arrhythmias, myocardial infarction and surgery), renal diseases (chronic renal failure), liver diseases (cirrhosis), diabetes mellitus type I, cancer history. Other joint diseases: knee deformity (knee varus greater than 10 degree or valgus greater than 20 degree), rheumatic arthritis, gouty arthritis, septic arthritis, serious meniscal tear, other autoimmune arthritis. Skin inflammatory of knee Knee pain caused by referred pain from spine disease or hip joint disease. Knee pain combined with pain from spine disease or hip disease. Immunosuppressive state Subjects who were injected with hyaluronic acid and PRP in the past 6 months Body mass index (BMI) greater than 30 Have a history of allergic reaction of any medication Participation in another clinical trial or treatment within 3 months Other pathologic conditions or circumstances that difficult participation in this study according to PI's evaluations
Facility Information:
Facility Name
Far Eastern Memorial Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

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Treatment of Knee Osteoarthritis With Autologous Mesenchymal Stromal Cell Product (RegStem)

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