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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week12, 24, 36, and 48
Awards & highlights

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.

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%
Muscle spasms
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%
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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Regenerative therapies for osteoarthritis, such as JointStem, utilize autologous adipose tissue-derived mesenchymal stem cells (AdMSC) to promote tissue repair and reduce inflammation. These stem cells can differentiate into various cell types, including chondrocytes, which are essential for cartilage repair. They also secrete bioactive molecules that modulate the immune response and reduce inflammation, potentially slowing the progression of OA. Platelet-rich plasma (PRP) is another common treatment that involves injecting concentrated platelets from the patient's blood into the affected joint. PRP releases growth factors that enhance tissue regeneration and reduce inflammation. These mechanisms are crucial for OA patients as they aim to restore joint function, alleviate pain, and improve quality of life by addressing the underlying causes of cartilage degradation and inflammation.
Administration of mesenchymal stem cells from adipose tissue at the hip joint of dogs with osteoarthritis: A systematic review.

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
~34 spots leftby Jul 2025
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