JointStem for Osteoarthritis, Knee

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Osteoarthritis, Knee+1 More
JointStem - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new stem cell treatment for knee osteoarthritis to see if it is more effective and safe than a placebo. 140 people will be randomly assigned to receive either the treatment or the placebo, and the trial will last 48 weeks.

Eligible Conditions
  • Osteoarthritis, Knee

Video Summary

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Week12, 24, 36, and 48

Baseline and Week 48
Western Ontario and McMaster Universities Arthritis Index (WOMAC) function Score
Week 12
Visual Analog Scale (VAS) score
Western Ontario and McMaster Universities Arthritis Index (WOMAC) subscale (Function)
Week 12
International Knee Documentation Committee (IKDC) score
Number and amount of rescue medication use
Total Western Ontario and McMaster Universities Arthritis Index (WOMAC) score
Western Ontario and McMaster Universities Arthritis Index (WOMAC) subscale (Pain)
Week 48
Kellgren-Lawrence grade
Structural changes in knee joint
Week12, 24, 36, and 48
36-Item Short Form health survey questionnaires (SF-36) score

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

JointStem
47%Injection site pain
37%Arthralgia
26%Joint swelling
21%Stiff knees
11%Nasopharyngitis
11%Bronchitis
11%Ligament sprain
5%Muscle spasms
5%Sinusitis
5%Hand-foot-and-mouth disease
5%Influenza
5%Herpes simplex
5%Meniscus injury
5%Cough
5%Headache
5%Injection site swelling
5%Back pain
5%Pain
5%Lower respiratory tract infection
5%Upper respiratory tract infection
5%Dyspepsia
5%Urinary tract infection
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT02674399) in the JointStem ARM group. Side effects include: Injection site pain with 47%, Arthralgia with 37%, Joint swelling with 26%, Stiff knees with 21%, Nasopharyngitis with 11%.

Trial Design

2 Treatment Groups

JointStem
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

140 Total Participants · 2 Treatment Groups

Primary Treatment: JointStem · Has Placebo Group · Phase 2 & 3

JointStem
Drug
Experimental Group · 1 Intervention: JointStem · Intervention Types: Drug
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo Control · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JointStem
2016
Completed Phase 2
~30

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week12, 24, 36, and 48

Who is running the clinical trial?

Nature Cell Co. Ltd.Lead Sponsor
4 Previous Clinical Trials
159 Total Patients Enrolled
1 Trials studying Osteoarthritis, Knee
28 Patients Enrolled for Osteoarthritis, Knee

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have osteoarthritis of the knee.
You have a knee OA score of ≥ 34 on the WOMAC function score at Screening and Baseline.
Subjects whose knee pain persists for at least 12 weeks (about 3 months) prior to screening and does not improve symptoms with non-operative treatment options.
You have knee pain ≥ 50 mm out of 100 mm on VAS at Screening and Baseline.
You have radiographic evidence of osteoarthritis in one knee and grade 1 or 2 in the other knee.
You are willing to discontinue all pain medications for osteoarthritis except rescue medication (< acetaminophen 3.25 g per day) at least 72 hours prior to screening and throughout the duration of study.
You are willing and able to give written informed consent for participation in the study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 31st, 2021

Last Reviewed: November 1st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Maryland50.0%
Pennsylvania16.7%
Virginia16.7%
Other16.7%
How old are they?
65+35.7%
18 - 6564.3%
What site did they apply to?
International Spine Pain, and Performance Center58.3%
Rothman Orthopaedic Institute33.3%
Hospital for Special Surgery8.3%
What portion of applicants met pre-screening criteria?
Met criteria72.2%
Did not meet criteria27.8%
How many prior treatments have patients received?
250.0%
3+50.0%
Why did patients apply to this trial?
  • "I have so much knee pain in both my legs that it is getting more and more difficult to walk."
What questions have other patients asked about this trial?
  • "Is this a scam?"

How responsive is this trial?

Most responsive sites:
  1. International Spine Pain, and Performance Center: < 24 hours
Average response time
  • < 2 Days
Typically responds via
Phone Call33.3%
Email66.7%