What side effects are associated with this type of intervention?

Common treatments for osteoarthritis, such as autologous adipose tissue-derived mesenchymal stem cells (AdMSC) and platelet-rich plasma (PRP), generally have a favorable safety profile but are not without risks. For AdMSC, potential side effects include pain at the injection site, swelling, and a low risk of infection. PRP injections may cause similar local reactions such as pain, tenderness, swelling, and bruising. Both treatments carry the general risks associated with intraarticular injections, including the possibility of local infection. It is important to discuss these potential side effects with a healthcare provider to make an informed decision.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically involving autologous adipose tissue-derived mesenchymal stem cells (AdMSC) for osteoarthritis. The FDA has approved other treatments for osteoarthritis, such as nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroid injections, and hyaluronic acid injections, which focus on pain relief and improving joint function. Regenerative therapies like platelet-rich plasma (PRP) and bone marrow-derived mesenchymal stem cells are being explored in clinical trials, but they have not yet received FDA approval for osteoarthritis treatment.

What other types of research exist?

Promising alternatives to JointStem for osteoarthritis treatment include: 1) Bone Marrow-Derived Mesenchymal Stem Cells (BM-MSCs), which have shown potential in clinical studies for knee osteoarthritis. 2) Platelet-Rich Plasma (PRP) injections, which have been studied for their ability to promote tissue repair and reduce inflammation. 3) Intra-articular injections of biologics like sprifermin, which has shown efficacy in reducing cartilage loss and promoting cartilage gain. 4) Minimally invasive total knee arthroplasty, which continues to improve in precision and outcomes for severe cases.

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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

Summary

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.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ week12, 24, 36, and 48

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Western Ontario and McMaster Universities Arthritis Index (WOMAC) function Score

Secondary study objectives

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%

Nasopharyngitis

11%

Bronchitis

11%

Ligament sprain

Muscle spasms

Hand-foot-and-mouth disease

Herpes simplex

Pain

Sinusitis

Upper respiratory tract infection

Headache

Meniscus injury

Dyspepsia

Cough

Injection site swelling

Influenza

Lower respiratory tract infection

Urinary tract infection

Back pain

100%

80%

60%

40%

20%

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

Do I qualify?Apply below to find out

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.