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Stem Cell Therapy

Stem Cell Treatment for Knee Osteoarthritis

Phase 2 & 3
Recruiting
Research Sponsored by Nature Cell Co. Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week12, 24, 36, and 48
Awards & highlights

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.

Who is the study for?
This trial is for adults with knee osteoarthritis who have significant pain and limited function in one knee, but less severe symptoms in the other. They must not have used certain medications or treatments recently and should be free of serious health issues like heart disease or cancer. Participants cannot have had stem cell therapy before and must agree to avoid specific pain medications during the study.Check my eligibility
What is being tested?
The trial is testing JointStem, a treatment using patient's own fat-derived stem cells, against a placebo. About 140 participants will be randomly assigned to receive either JointStem or a placebo injection in their knees. The study aims to determine if JointStem can improve knee function and reduce pain more effectively than a placebo.See study design
What are the potential side effects?
Potential side effects are not detailed here, but may include reactions at the injection site, infection risk due to immune system changes from stem cell therapy, allergic reactions to components of the treatment, or complications from liposuction required to harvest adipose tissue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been experiencing knee pain for at least 3 months and it has not improved with non-surgical treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week12, 24, 36, and 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and week12, 24, 36, and 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Western Ontario and McMaster Universities Arthritis Index (WOMAC) function Score
Secondary outcome measures
36-Item Short Form health survey questionnaires (SF-36) score
Cartilage defect area changes in knee joint
International Knee Documentation Committee (IKDC) score
+6 more

Side effects data

From 2018 Phase 2 trial • 28 Patients • NCT02674399
47%
Injection site pain
37%
Arthralgia
26%
Joint swelling
21%
Stiff knees
11%
Bronchitis
11%
Nasopharyngitis
11%
Ligament sprain
5%
Hand-foot-and-mouth disease
5%
Herpes simplex
5%
Pain
5%
Sinusitis
5%
Upper respiratory tract infection
5%
Headache
5%
Meniscus injury
5%
Dyspepsia
5%
Cough
5%
Muscle spasms
5%
Injection site swelling
5%
Influenza
5%
Lower respiratory tract infection
5%
Urinary tract infection
5%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
JointStem
Synvisc-One

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: JointStemExperimental Treatment1 Intervention
Autologous Adipose tissue derived Mesenchymal Stem Cells(AdMSC)
Group II: PlaceboPlacebo Group1 Intervention
Normal Saline with Autologous Serum
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JointStem
2016
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

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

Media Library

Osteoarthritis Clinical Trial 2023: JointStem Highlights & Side Effects. Trial Name: NCT04368806 — Phase 2 & 3
JointStem (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04368806 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are investigators enrolling participants for this clinical trial at this time?

"That is correct, the online clinicaltrials.gov registry indicates that this research is currently looking for volunteers. This particular trial was first advertised on May 26th, 2021 and was last updated on October 26th, 2022. There are 7 research sites across the country and a total of 140 participants are needed."

Answered by AI

Who else is applying?

What state do they live in?
District of Columbia
Pennsylvania
Maryland
Other
How old are they?
65+
18 - 65
What site did they apply to?
Rothman Orthopaedic Institute
Hospital for Special Surgery
Other
International Spine Pain, and Performance Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2
3+
1

What questions have other patients asked about this trial?

Is this a scam? Is this like that Regnenex treatment? Similar?
PatientReceived no prior treatments

Why did patients apply to this trial?

I have tried many options and none has worked. I've tried non-surgical procedures and nothing has worked.
PatientReceived 1 prior treatment
I am interested in alternative approaches to knee osteoarthritis. I’m tired of chronic knee pain and don’t want a knee replacement.
PatientReceived no prior treatments
Have taken cortisone injections but the knee pain has not gone away.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. International Spine Pain, and Performance Center: < 24 hours
Average response time
  • < 2 Days
~38 spots leftby Feb 2025