Adipose Derived MSCs for Osteoarthritis

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Mayo Clinic

Must not be taking: Anticoagulants, Herbal supplements

Disqualifiers: Pregnancy, Hip deformity, Infections, BMI > 35, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1-2 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether injections of stem cells taken from a participant's own fat can safely and effectively reduce pain from hip osteoarthritis (OA). Researchers are examining the effectiveness of different dosages, with one group receiving a single injection and another group receiving two injections a month apart. Individuals with hip OA symptoms for over three months who have not found relief from treatments like physical therapy or anti-inflammatory medications might be suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Do I need to stop my current medications to join the trial?

The trial requires that you stop taking herbal therapies or supplements 4 weeks before joining and avoid them until 30 days after treatment. You must also have a stable dose of non-steroidal anti-inflammatory medications for at least 4 weeks before starting and maintain it until 30 days after treatment. If you are on anticoagulant medications, you may not be eligible to participate.

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

Research has shown that using a person's own fat-derived cells is generally safe for individuals with osteoarthritis. In one study, patients who received a single injection of these cells reported significant pain relief and improved movement. Another review found these cells effective and safe, even for older patients.

For those considering two injections, evidence also supports their safety. Multiple studies have found that both single and repeated injections improve pain without major safety concerns. Overall, these treatments appear well-tolerated, making them promising options for managing hip osteoarthritis. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Unlike standard treatments for osteoarthritis, which often rely on pain relief through medications like NSAIDs or corticosteroid injections, the treatment using Autologous Adipose Derived Mesenchymal Stromal Cells (MSCs) is unique because it utilizes the body's own cells to potentially repair and regenerate damaged tissue. This innovative approach harnesses MSCs extracted from a patient's own fat tissue, offering a personalized treatment option that may promote healing and reduce inflammation directly at the affected site. Researchers are excited about this treatment because it offers a promising alternative that could not only alleviate symptoms but also address the underlying causes of osteoarthritis, potentially leading to longer-lasting relief. Additionally, the delivery method via ultrasound-guided injections ensures precise placement of the cells, enhancing treatment effectiveness.

What evidence suggests that autologous adipose derived mesenchymal stromal cells might be an effective treatment for osteoarthritis?

Research has shown that using a person's own fat cells, known as AD-MSCs, might help treat osteoarthritis. Studies have found that patients receiving these cells experienced noticeable relief from knee osteoarthritis symptoms, with less pain and improved joint function. In this trial, participants will receive either a single injection or two injections of AD-MSCs into the hip. AD-MSCs provide quick pain relief and lasting benefits. These encouraging results suggest they might also effectively treat hip osteoarthritis. ^{2 6 7 8 9}

Who Is on the Research Team?

Aaron J Krych

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with chronic hip osteoarthritis (OA) pain, who've tried conservative treatments without surgery plans for the next year. Participants must be able to walk unassisted and agree to use contraception if of childbearing potential. Exclusions include pregnancy, allergies to study drugs, recent injections in the target hip, BMI over 35, certain medication use, infectious diseases like HIV or hepatitis, history of cancer except some skin cancers, drug abuse or significant cardiovascular and other systemic diseases.

Inclusion Criteria

At least 12 months must go by after the last injection before surgery is planned in the target hip.

Completed general physical and well-being evaluation with their primary care provider within the past 12 months.

• Persons of childbearing potential must have a negative pregnancy test prior to receiving the study drug and will agree to use adequate contraception (hormonal or barrier method or abstinence) from the time of screening to a period of 1 year following completion of the drug treatment cycle. Females of childbearing potential are defined as premenopausal and not surgically sterilized, or post-menopausal for fewer than 2 years. A urine pregnancy test will be performed prior to the administration of the study drug to confirm negative results. If the urine pregnancy test is positive, the study drug will not be administered and the result will be confirmed by a serum pregnancy test. Serum pregnancy tests will be performed at a central clinical laboratory, whereas urine pregnancy tests will be performed by qualified personnel using kit

Exclusion Criteria

You have a condition in your blood vessels or nerves that affects your lower limbs and could make it unsafe to receive treatment directly in your joints.

Pregnant or nursing, or planning on becoming pregnant during the study period

You are allergic to the numbing medicine or other ingredients in the study drug.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a single dose or two doses of autologous culture-expanded adipose-derived mesenchymal stromal cells (AMSCs) via ultrasound guided intra-articular hip injection

1-2 months

1-2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of cartilage thickness, hip scores, and adverse events

24 months

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Autologous Adipose Derived Mesenchymal Stromal Cells

Trial Overview

The trial tests whether injecting a patient's own cultured adipose-derived mesenchymal stromal cells (AMSCs) into their painful hip can safely relieve OA pain and which dose works best. It involves fat harvesting from participants followed by laboratory cell expansion before injection back into the affected hip joint.

How Is the Trial Designed?

Group I: Two Injections Experimental Treatment 1 Intervention

Two-dose administration (2 x ultrasound guided injections) of Autologous Adipose Derived Mesenchymal Stromal Cells into the hip with one month interval between doses

Group II: Single Injection Experimental Treatment 1 Intervention

Single administration of Autologous Adipose Derived Mesenchymal Stromal Cells into the hip by single ultrasound guided injection

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Adipose-derived stem cells (ASCs) have shown significant potential in regenerative therapy due to their ability to differentiate into various cell types and modulate immune responses, making them a promising option for treating osteoarthritis (OA).

Current research indicates that ASCs could provide a novel approach to address the pathophysiology of OA, which currently lacks curative treatments, highlighting their potential role in future cell therapies for this common joint disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adipose derived stem cells for regenerative therapy in osteoarticular diseases. Pers, YM., Jorgensen, C.[2017]

The study evaluated the safety and efficacy of autologous adipose-derived stem cell (ASC) therapies in 17 patients with severe conditions, finding no serious adverse events over a follow-up period of up to 54 months.

Both ASC-derived products—a scaffold-free osteogenic graft for bone non-union and a biological dressing for chronic wounds—were successfully manufactured and implanted without contamination or genomic issues, demonstrating their feasibility for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human Adipose-Derived Mesenchymal Stem Cells in Cell Therapy: Safety and Feasibility in Different "Hospital Exemption" Clinical Applications. Vériter, S., André, W., Aouassar, N., et al.[2022]

A review of 2,011 injections of autologous mesenchymal stem cells (AMSCs) for treating arthritis found no specific adverse events, indicating that these injections are completely safe.

The study concluded that AMSCs do not pose an increased risk of complications such as infections or tumor formation compared to traditional arthritis treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Administration of Autologous Mesenchymal Cells for the Treatment of Arthritis. Prodromos, C., Rumschlag, T.[2021]

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