NCT03007576

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2017

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 2, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

November 13, 2019

Status Verified

November 1, 2019

Enrollment Period

2.1 years

First QC Date

December 21, 2016

Last Update Submit

November 10, 2019

Conditions

Osteoarthritis,Knee

Outcome Measures

Primary Outcomes (2)

  • Safety of RegStem by incidence of adverse events and changes in physical examinations, vital signs and the results of clinical lab tests.

    48 weeks

  • Clinical assessment of International Knee Documentation Committee (IKDC) score

    Assess symptoms of knee, sport activity and function of knee

    48 weeks

Secondary Outcomes (4)

  • Clinical assessment of Knee injury and Osteoarthritis Outcome Score (KOOS)

    48 weeks

  • Clinical assessment of visual analogue scale (VAS)

    48 weeks

  • Clinical assessment of knee X-ray

    48 weeks

  • Clinical assessment of knee MRI

    48 weeks

Study Arms (1)

RegStem

EXPERIMENTAL

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

Biological: RegStem

Interventions

RegStemBIOLOGICAL

RegStem, 1.5 ml, one injection

Also known as: MSC
RegStem

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far Eastern Memorial Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2016

First Posted

January 2, 2017

Study Start

August 1, 2017

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

November 13, 2019

Record last verified: 2019-11

Locations

TW(1)