Stem Cell Treatment for Knee Osteoarthritis

Recruiting at 7 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

Trial Summary

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.

What data supports the effectiveness of the treatment JointStem for knee osteoarthritis?

Research shows that treatments using bone marrow concentrate, which is similar to JointStem, have shown encouraging results in improving symptoms of knee osteoarthritis. Additionally, mesenchymal stem cells, a component of such treatments, have the potential to help repair damaged joint tissues. ^{1 2 3 4 5}

Is stem cell treatment for knee osteoarthritis safe?

Stem cell treatments for knee osteoarthritis, including those using mesenchymal stromal cells (MSCs), have generally shown a favorable safety profile. Most adverse events reported were mild, such as temporary knee swelling and pain, with very few severe cases requiring hospitalization. Preclinical studies in animals also support the safety of these treatments, showing no systemic reactions or joint damage. ^{6 7 8 9 10}

How is the JointStem treatment for knee osteoarthritis different from other treatments?

JointStem is unique because it uses stem cells, which are special cells that can develop into different types of cells, to potentially repair and regenerate knee tissue. This approach is minimally invasive and aims to address the underlying causes of osteoarthritis, unlike traditional treatments that mainly focus on symptom relief. ^{11 12 13 14 15}

What is the purpose of this trial?

This trial is testing a new treatment that uses cells from a patient's own fat to help repair knee damage in people with knee osteoarthritis. The cells are injected into the knee to reduce pain and improve joint function. This type of therapy has been increasingly studied and used for treating knee osteoarthritis due to its potential to reduce pain and improve joint function.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy of autologous bone marrow concentrate for knee osteoarthritis with and without adipose graft. [2022]

2. England pubmed.ncbi.nlm.nih.gov

A dose response analysis of a specific bone marrow concentrate treatment protocol for knee osteoarthritis. [2022]

3. Canada pubmed.ncbi.nlm.nih.gov

Quantification of cells expressing mesenchymal stem cell markers in healthy and osteoarthritic synovial membranes. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Knee Osteoarthritis: Clinical and MRI Outcomes After Multiple Intra-Articular Injections With Expanded Autologous Adipose-Derived Stromal Cells or Platelet-Rich Plasma. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Mesenchymal stem cell therapy in joint disease. [2005]

6. England pubmed.ncbi.nlm.nih.gov

Safety Studies for Use of Adipose Tissue-Derived Mesenchymal Stromal/Stem Cells in a Rabbit Model for Osteoarthritis to Support a Phase I Clinical Trial. [2020]

7. France pubmed.ncbi.nlm.nih.gov

Safety and efficacy of adipose-derived mesenchymal stem cells for knee osteoarthritis: A systematic review and m-analysis. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Clinical efficacy and safety of stem cell therapy for knee osteoarthritis: A meta-analysis. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Cultured/Noncultured Mesenchymal Stromal Cells without Concurrent Surgery for Knee Osteoarthritis: A Systematic Review of Randomized Controlled Trials. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Clinical efficacy and safety of mesenchymal stem cell transplantation for osteoarthritis treatment: A meta-analysis. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Editorial Commentary: Stem Cell Treatment for Knee Osteoarthritis: Holy Grail or Tin Cup? [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Short-Term Outcomes in Treatment of Knee Osteoarthritis With 4 Bone Marrow Concentrate Injections. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Adult human mesenchymal stem cells delivered via intra-articular injection to the knee following partial medial meniscectomy: a randomized, double-blind, controlled study. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Multiple intra-articular injections of allogeneic bone marrow-derived stem cells potentially improve knee lesions resulting from surgically induced osteoarthritis: an animal study. [2019]

15. Iran pubmed.ncbi.nlm.nih.gov

Effect of Conditioned Medium from IGF1-Induced Human Wharton's Jelly Mesenchymal Stem Cells (IGF1-hWJMSCs-CM) on Osteoarthritis. [2022]