Stem Cell Treatment for Knee Osteoarthritis

Recruiting at 15 trial locations

Overseen By Sabrina M. Strickland, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Nature Cell Co. Ltd.

Must not be taking: Anti-inflammatories, Oral steroids

Disqualifiers: BMI > 35, Cancer, Heart diseases, Autoimmune diseases, Inflammatory joint disorders, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 1 day

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new stem cell treatment called JointStem to determine its effectiveness for knee osteoarthritis. The researchers aim to discover if stem cells from a person’s own fat tissue can reduce pain and improve knee function better than a placebo, which is a harmless substance used for comparison. Participants will be randomly assigned to receive either the stem cell treatment or the placebo. This trial may suit individuals diagnosed with knee osteoarthritis who experience significant knee pain and have not found relief with other treatments. As a Phase 2/3 trial, it measures the treatment's effectiveness in a larger group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking research.

Will I have to stop taking my current medications?

Yes, you will need to stop taking all pain medications for osteoarthritis, except for a limited amount of acetaminophen, at least 72 hours before the screening and throughout the study. Additionally, if you have taken anti-inflammatory drugs or certain other medications recently, you must have a 14-day period without them before screening.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In a previous study, patients who received stem cells from their own fat tissue showed better health outcomes. Research indicates that this treatment is generally safe and well-tolerated. Another study found that using these stem cells was effective and safe, particularly for older adults with knee problems. These studies have reported no major safety concerns, suggesting that the treatment is usually safe for use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

JointStem is unique because it uses autologous adipose tissue-derived mesenchymal stem cells (AdMSC) to potentially repair damaged knee joint tissues. Unlike standard treatments for knee osteoarthritis, which often include pain relievers and anti-inflammatory medications, this approach aims to regenerate the joint itself. Researchers are excited about JointStem because it targets the root cause of joint deterioration rather than just alleviating symptoms, offering hope for a more lasting solution.

What evidence suggests that JointStem might be an effective treatment for knee osteoarthritis?

Research has shown that JointStem, a treatment in this trial, uses special cells from a patient's own fat tissue and may help treat knee osteoarthritis. These cells can enhance knee function and reduce pain. One review found that patients experienced better results and the treatment was safe, particularly for older adults. Another study found that injecting these cells directly into the knee provided significant pain relief and improved knee function. These findings suggest that JointStem could be an effective option for those with knee osteoarthritis. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Subject who has ≥ 34 on WOMAC function score at Screening and Baseline

Subject who had osteoarthritis of knee diagnosed (according to the clinical and American College of Rheumatology Criteria)

You have osteoarthritis of the knee.

Exclusion Criteria

Subject who has heart diseases (myocardial infarction, coronary artery bypass graft surgery, arrhythmia, or other serious heart diseases) or has history of heart diseases within 6 months prior to Screening

Subject who have received any intra-articular therapy in any joint within 6 months prior to Screening, or surgery on the relevant knee including articular endoscopic procedures within 6 months prior to Screening

Subject who have received long-acting hyaluronic acid injection (e.g. Synvisc-One®, etc.) within 12 months prior to Screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Baseline and Randomization

Baseline assessments and randomization, including lipoaspiration for treatment preparation

2 weeks

1 visit (in-person)

Treatment

Participants receive intra-articular injection of JointStem or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 weeks

5 visits (in-person) at Weeks 4, 12, 24, 36, and 48

What Are the Treatments Tested in This Trial?

Interventions

• JointStem
• Placebo Control

Trial Overview

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.

How Is the Trial Designed?

Group I: JointStem Experimental Treatment 1 Intervention

Autologous Adipose tissue derived Mesenchymal Stem Cells(AdMSC)

Group II: Placebo Placebo Group 1 Intervention

Normal Saline with Autologous Serum

Who Is Running the Clinical Trial?

Nature Cell Co. Ltd.

Lead Sponsor

Trials

5

Recruited

300+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11575038/

Clinical outcomes of autologous adipose-derived ...

Clinical outcomes of autologous AD-MSCs therapy in knee osteoarthritis are correlated with stem cell stemness and senescence.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02658344?term=AREA%5BBasicSearch%5D(%22mesenchymal%20stem%20cells%22%20AND%20%22osteoarthritis%22)&rank=3

Clinical Trial to Evaluate Efficacy and Safety of JOINTSTEM ...

The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S0976566224004739

Safety and efficacy of autologous adipose-derived stem ...

The current systematic review demonstrated that using autologous adipose-derived stem cells improved clinical outcomes and is effective and safe in elderly ...

4.

arthritis-research.biomedcentral.com

arthritis-research.biomedcentral.com/articles/10.1186/s13075-023-03134-3

Effect of intra-knee injection of autologous adipose stem cells ...

Effect of intra-knee injection of autologous adipose stem cells or mesenchymal vascular components on short-term outcomes in patients with knee ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6525553/

Intra‐Articular Injection of Autologous Adipose Tissue‐ ...

An intra‐articular injection of autologous adipose tissue‐derived mesenchymal stem cells provided satisfactory functional improvement and pain relief for ...