What side effects are associated with this type of intervention?

Common treatments for osteoarthritis, such as platelet-rich plasma (PRP) and mesenchymal stem cell (MSC) therapies, generally have minor and transient side effects. PRP injections can cause pain, bleeding, tenderness, swelling, and bruising at the injection site, with a risk of local infection. MSC therapies, while less commonly detailed, may involve similar injection-related risks. Both treatments are considered relatively safe but lack extensive long-term safety data.

What prior FDA approvals exist?

The FDA has approved several treatments for osteoarthritis, primarily focusing on pain relief and inflammation reduction. These include nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen, corticosteroid injections, and hyaluronic acid injections. While regenerative medicine using Adipose-Derived Regenerative Cells (ADRC) is being studied, there are no specific FDA approvals for ADRC injections for osteoarthritis as of now. Other regenerative approaches, such as platelet-rich plasma (PRP) therapy, are also under investigation but lack extensive FDA approval for osteoarthritis treatment.

What other types of research exist?

Promising alternatives to ADRC injection for osteoarthritis treatment include: 1) Allogeneic adipose-derived stem cell (ADMSC) transplantation, which has shown efficacy in reducing markers like MMP-13 and DDR2 in animal models. 2) Platelet-rich plasma (PRP) therapy, which has been studied for its potential to accelerate healing and reduce pain in musculoskeletal injuries. 3) Mesenchymal stem cell (MSC) therapy from sources like bone marrow or umbilical cord, which are being explored for their regenerative capabilities and safety profile. 4) Intra-articular injections of biologics such as hyaluronic acid or growth factors, which aim to improve joint lubrication and reduce inflammation.

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Stem Cell Therapy

Stem Cell Injection for Osteoarthritis

N/A

Recruiting

Led By Thomas Boetel, MD

Research Sponsored by InGeneron, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male and female subjects, between 18 and 75 years of age.

Have documented the diagnosis of facet joint osteoarthritis from L1 to S1 in the opinion of the investigator.

Timeline

Screening 2 weeks

Treatment Varies

Follow Up 3 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for people with long-term back pain caused by joint damage. The treatment uses special cells taken from the patient's own fat to help heal the painful area. The goal is to see if this new method works better than standard treatments.

Who is the study for?

Adults aged 18-75 with chronic lower back pain due to facet joint osteoarthritis, who have not improved after 3 months of conservative care and physical therapy. Participants must have a baseline pain score of at least 4 out of 10 and show significant pain relief after a diagnostic injection. Exclusions include active cancer, high risk for bleeding or infection, severe autoimmune diseases, recent drug abuse, pregnancy or nursing women, extreme obesity (BMI >40), and certain medication use.

What is being tested?

The trial is testing the safety and effectiveness of injecting Adipose-derived Regenerative Cells (ADRC) compared to corticosteroid injections in treating lower back pain caused by osteoarthritis in the facet joints. It's randomized and controlled to ensure reliable results.

What are the potential side effects?

Potential side effects may include reactions at the injection site such as pain or swelling, increased risk of infection due to stem cell manipulation, allergic reactions to components used during procedures like contrast agents or local anesthetics.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 75 years old.

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My doctor has confirmed I have arthritis in my lower back joints.

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I have been diagnosed with symptomatic facet joint syndrome.

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I've tried various non-surgical back pain treatments for 3 months without improvement.

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My pain level is at least 4 out of 10 over a day.

Timeline

Screening ~ 2 weeks2 visits

Treatment ~ Varies

Follow Up ~ 3 days5 visits

Screening ~ 2 weeks

Treatment ~ Varies

Follow Up ~3 days

This trial's timeline: 2 weeks for screening, Varies for treatment, and 3 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Safety - Incidence of Treatment-Emergent Adverse Events experimental group

Secondary study objectives

Efficacy - Change in Function Scores on the EQ-5D at All Follow-up Visits

Efficacy - Change in Function Scores on the Oswestry Disability Index at All Follow-up Visits

Efficacy - Change in Pain Scores on the VAS Scale at All Follow-up Visits

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Adipose-derived stem cell injectionExperimental Treatment1 Intervention

ADRC treatment group will receive ADRCs yielded from processing of lipoaspirate by a fluoroscopic-guided injection into the affected segment. The segment will consist of 2 joints per level and up to two levels (no more than 4 joints) injected during the procedure.

Group II: Corticosteroid injectionActive Control1 Intervention

The control group will undergo standard fluoroscopy guided injection of glucocorticoids and local anesthetics.

0 / 6Eligibility criteria met

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

Common treatments for osteoarthritis (OA) include analgesics like acetaminophen, which reduce pain by inhibiting pain signals; NSAIDs such as ibuprofen and naproxen, which reduce inflammation and pain by blocking COX enzymes; and glucocorticoids, which provide short-term relief by reducing inflammation. Regenerative medicine approaches, such as adipose-derived regenerative cells (ADRCs), are being studied for their potential to repair and regenerate damaged cartilage. ADRCs may exert their effects through paracrine signaling, releasing growth factors and cytokines that promote tissue repair and reduce inflammation. This is particularly important for OA patients as it offers a potential to not only alleviate symptoms but also address the underlying joint damage.

The paracrine effect of adipose-derived stem cells inhibits osteoarthritis progression.Mesenchymal stem cell therapy in osteoarthritis: advanced tissue repair or intervention with smouldering synovial activation?