Stem Cell Injection for Osteoarthritis

Recruiting at 1 trial location

Overseen By Claire Huang, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: InGeneron, Inc.

Must not be taking: Anticoagulants, Immunosuppressants, Corticosteroids, others

Disqualifiers: Pregnancy, Obesity, Active malignancy, others

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

Compensation: Varies

Number of Visits: 5

Duration: 1 day

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for people with chronic low back pain due to facet joint osteoarthritis. It compares the safety and effectiveness of adipose-derived (fat-based) stem cell injections with standard corticosteroid injections. Participants who have experienced back pain for at least six months and have not found relief from other treatments might be suitable candidates. The goal is to determine if stem cell injections can offer better pain relief or improve joint function compared to the usual treatment. As an unphased trial, this study provides a unique opportunity to investigate innovative treatments that could potentially offer new options for pain relief.

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

The trial protocol does not specify if you need to stop taking your current medications. However, certain medications like systemic corticosteroids and anticoagulants may need to be adjusted or stopped before participating. It's best to discuss your specific medications with the trial team.

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

Research has shown that injections using stem cells from fat tissue are generally well-tolerated by people with osteoarthritis. One study examined their use for a type of back arthritis and found no major safety issues, suggesting the treatment is relatively safe for similar conditions.

These fat-derived stem cells have also been used successfully in other arthritis treatments. They can help renew and repair tissues, making them a promising option.

Corticosteroid injections are another common treatment to manage pain and swelling. When administered by a doctor, they are safe, though some people might experience temporary soreness at the injection site.

Overall, past research has demonstrated good safety for both treatments, making them viable options for those considering participation in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike standard treatments for osteoarthritis, which often involve pain relief through medications like NSAIDs or corticosteroids, adipose-derived stem cell injections offer a regenerative approach. This treatment is unique because it uses stem cells harvested from a patient's own fat tissue, aiming to repair and regenerate damaged joint tissues. Researchers are excited about this method as it targets the root cause of joint degeneration rather than just alleviating symptoms, potentially leading to longer-lasting relief and improved joint function. Additionally, the minimally invasive procedure might reduce downtime and side effects compared to more traditional surgical interventions.

What evidence suggests that this trial's treatments could be effective for osteoarthritis?

Research shows that stem cells taken from fat tissue, known as adipose-derived stem cells (ADSCs), may help treat osteoarthritis. These cells can reduce pain and improve joint function by aiding tissue repair. Studies have found that ADSCs effectively treat knee osteoarthritis, suggesting they might also help with back pain caused by osteoarthritis. Although more research is needed specifically for back pain, current evidence for joint conditions is promising. In this trial, one group of participants will receive adipose-derived stem cell injections, while another group will receive corticosteroid injections. Corticosteroids are commonly used to reduce inflammation and relieve pain but do not support long-term healing like stem cells might. These findings suggest that adipose-derived stem cells could offer a more lasting solution for pain related to osteoarthritis. ^{1 3 4 5 6}

Who Is on the Research Team?

Thomas Boetel, MD

Principal Investigator

Sanford Health

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My doctor diagnosed me with arthritis in my lower back joints.

I have been diagnosed with symptomatic facet joint syndrome.

I have had chronic low back pain for at least 6 months.

Exclusion Criteria

I am a woman who can have children and I use or plan to use birth control during the study.

I haven't had any lower back injections in the last 3 months, except for certain ones over 2 weeks ago.

I am currently taking NSAIDs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the treatment group undergo a small liposuction procedure and receive an ultrasound-guided injection of adipose-derived stem cells into the facet joint. The control group receives a corticosteroid injection.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of adverse events, function, and pain scores.

52 weeks

4 visits (in-person) at 6, 12, 26, and 52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Adipose-derived stem cell injection
• Corticosteroid injection

Trial Overview 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.

How Is the Trial Designed?

Group I: Adipose-derived stem cell injection Experimental Treatment 1 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 injection Active Control 1 Intervention

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

Adipose-derived stem cell injection is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Adipose-derived stem cell injection for:

• Osteoarthritis of the facet joint
• Chronic lumbar back pain

Approved in European Union as Adipose-derived stem cell injection for:

• Orthopedic conditions such as osteoarthritis, joint arthritis, degenerative vertebral disks

Approved in Canada as Adipose-derived stem cell injection for:

• Orthopedic conditions such as osteoarthritis, joint arthritis, degenerative vertebral disks

Who Is Running the Clinical Trial?

InGeneron, Inc.

Lead Sponsor

Trials

9

Recruited

710+

Sanford Health

Collaborator

Trials

53

Recruited

2,067,000+

Published Research Related to This Trial

Intra-articular injections of platelet-rich plasma (PRP) and autologous conditioned serum (ACS) showed better clinical outcomes for patients with early osteoarthritis of the knee compared to traditional treatments like hyaluronic acid (HA) and corticosteroids, based on evaluations at 6 months using the WOMAC and VAS scales.

There was no significant difference in effectiveness between PRP and ACS, indicating that both biologics are similarly effective options for managing early osteoarthritis after initial conservative treatments have failed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Autologous Conditioned Serum (ACS), Platelet-Rich Plasma (PRP), Hyaluronic Acid (HA) and Steroid for Early Osteoarthritis Knee: A Comparative Analysis. Khurana, A., Goyal, A., Kirubakaran, P., et al.[2022]

Injectable corticosteroids can cause side effects like lipoatrophy, especially when misused by non-dermatologists, highlighting the need for careful administration.

Serial saline injections have been found to be a safe, quick, and cost-effective treatment for steroid-induced lipoatrophy in children, providing a practical alternative to manage this side effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reversal of steroid-induced lipoatrophy with serial injections of isotonic saline in a child. Daruwalla, SB., Dhurat, RS., Sharma, A., et al.[2021]

A 48-year-old woman with well-controlled HIV developed iatrogenic Cushing syndrome and adrenal insufficiency after receiving an epidural triamcinolone injection while on ritonavir-containing antiretroviral therapy, highlighting the risks of drug interactions with glucocorticoids.

Changing her ART regimen to a non-protease inhibitor led to symptom improvement without the need for hydrocortisone replacement, emphasizing the importance of careful medication management and monitoring in HIV patients receiving corticosteroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Iatrogenic cushing syndrome secondary to ritonavir-epidural triamcinolone interaction: an illustrative case and review. Sadarangani, S., Berg, ML., Mauck, W., et al.[2021]

In a study of 117 patients with rheumatoid arthritis, using elastic wrist orthoses for 48 hours after glucocorticoid injections did not significantly reduce the relapse of wrist synovitis compared to normal activity, with 24 relapses in the orthoses group versus 14 in the active group.

The findings suggest that postinjection immobilization may not be beneficial for wrist treatments, indicating that recommendations for postinjection care should be tailored to the specific joint being treated, rather than applying results from knee studies to other joints.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised controlled study of postinjection immobilisation after intra-articular glucocorticoid treatment for wrist synovitis. Weitoft, T., Rönnblom, L.[2019]

In a study of 79 children with juvenile chronic arthritis, triamcinolone injections were found to significantly improve the likelihood of remission compared to methylprednisolone, with results showing a strong statistical significance (p < 0.0005).

The length of remission was associated with the proportion of polymorphonuclear leucocytes in the synovial fluid, indicating that patients with lower levels of these cells experienced longer remissions, suggesting a potential biomarker for treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-articular glucocorticoids in early juvenile chronic arthritis. Honkanen, VE., Rautonen, JK., Pelkonen, PM.[2019]

Triamcinolone acetonide extended-release (ER) 32 mg significantly reduces knee osteoarthritis pain over 24 weeks compared to placebo, while also improving stiffness and physical function, demonstrating its efficacy as a treatment option.

The formulation of triamcinolone acetonide ER in PLGA microspheres allows for prolonged release in the joint, minimizing systemic exposure and related side effects, making it a safer alternative to traditional corticosteroid injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Triamcinolone Acetonide Extended-Release: A Review in Osteoarthritis Pain of the Knee. Paik, J., Duggan, ST., Keam, SJ.[2023]

A 27-year-old woman with severe subcutaneous atrophy and hypopigmentation after a triamcinolone acetonide injection experienced significant improvement following a single autologous fat transplantation procedure, indicating its efficacy in treating these complications.

While most cases of atrophy and hypopigmentation resolve on their own within a year, this case suggests that autologous fat transplantation can be a highly effective treatment for severe cases, enhancing skin quality and softening scars.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous fat transplantation for multiple scattered steroid atrophy and hypopigmentation: A case report. Ni, M., Wang, D.[2023]

In a double-blind study involving 30 patients with rheumatoid arthritis, all three intra-articular steroid preparations (prednisolone t-butyl acetate, methyl prednisolone acetate, and triamcinolone hexacetonide) showed thermographic improvement in knee synovitis, with triamcinolone demonstrating the greatest and longest-lasting effect.

Despite the local improvements in knee symptoms, no significant overall systemic improvement was observed after a single injection of any steroid, although all three preparations suppressed the body's natural cortisol production.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A thermographic and clinical comparison of three intra-articular steroid preparations in rheumatoid arthritis. Bird, HA., Ring, EF., Bacon, PA.[2022]

In a study involving 145 patients with knee osteoarthritis, intramuscular (IM) glucocorticoid injection showed noninferiority to intra-articular (IA) injection in reducing knee pain at 8 and 24 weeks, but not at 4 weeks, indicating that while IM may be effective, it may take longer to show benefits compared to IA injections.

Both injection methods resulted in clinically relevant pain improvements, and the most common side effects were mild, such as hot flushes and headaches, suggesting that both techniques are generally safe for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Intramuscular vs Intra-articular Glucocorticoid Injection on Pain Among Adults With Knee Osteoarthritis: The KIS Randomized Clinical Trial. Wang, Q., Mol, MF., Bos, PK., et al.[2022]

Intra-articular administration of triamcinolone hexacetonide (THG) significantly improved weight distribution and pain scores in patients over a period of 180 days compared to saline, with notable improvements starting as early as 8 days post-treatment.

The study involved 40 hip joints in children with a mean age of 6.5 years, and THG showed better outcomes in joint function and thermographic evaluations, indicating its efficacy in managing joint issues, although factors like age and radiographic findings influenced treatment response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The intra-articular administration of triamcinolone hexacetonide in the treatment of osteoarthritis. Its effects in a naturally occurring canine osteoarthritis model. Alves, JC., Santos, A., Jorge, P., et al.[2023]

In a study involving 100 patients with knee osteoarthritis, both triamcinolone hexacetonide (TH) and methylprednisolone acetate (MA) injections significantly reduced pain at 4 weeks, with sustained improvements observed up to 24 weeks.

There was no significant difference in efficacy between TH and MA, as both treatments showed similar outcomes in pain relief and functional improvement, indicating that either corticosteroid can be effectively used for managing knee OA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Triamcinolone Hexacetonide versus Methylprednisolone Acetate Intraarticular Injections in Knee Osteoarthritis: A Randomized, Double-blinded, 24-week Study. Lomonte, AB., de Morais, MG., de Carvalho, LO., et al.[2022]

In a study of over 1.3 million epidural corticosteroid injections (ESIs) from 2009 to 2015, the rate of serious spinal adverse events (SSAEs) was found to be low at 8.1 per 1,000,000 patients.

Cervical and thoracic ESIs were associated with a significantly higher risk of SSAEs (29.4 per 1,000,000) compared to lumbar and sacral injections (5.1 per 1,000,000), while the risk was similar across different corticosteroid formulations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of serious spinal adverse events associated with epidural corticosteroid injections in the Medicare population. Eworuke, E., Crisafi, L., Liao, J., et al.[2022]

In a study of 600 patients receiving epidural steroid injections, both dexamethasone and betamethasone showed similar effectiveness in pain relief at 2 weeks, with around 33% of patients reporting significant improvement.

However, betamethasone was associated with fewer adverse events and greater reductions in pain and disability scores compared to dexamethasone, making it the preferred choice for epidural steroid injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the efficacy and safety of epidural steroid injection using a nonparticulate steroid, dexamethasone or betamethasone: a double-blind, randomized, crossover, clinical trial. Lee, GY., Lee, JW., Lee, E., et al.[2022]

Citations

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Adipose-derived regenerative cells (ADRCs) in ... Adipose-derived regenerative cells (ADRCs) have emerged as a transformative tool in regenerative medicine, offering multifaceted therapeutic potential due ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40369655/

The role of adipose-derived stem cells in knee ... While MSCs from bone marrow and umbilical cord have shown efficacy in treating OA, adipose-derived MSCs (ADMSC) are more accessible and cost- ...

3. thelittletonclinic.com thelittletonclinic.com/adipose-derived-stem-cells-a-new-frontier-for-treating-knee-pain/

Adipose-Derived Stem Cells: A Solution for Knee Pain Adipose-derived stem cells (ADSCs) are a type of mesenchymal stem cell found in fat tissue. Like other stem cells, they are capable of self-renewal and can ...

4. stemcellres.biomedcentral.com stemcellres.biomedcentral.com/articles/10.1186/s13287-025-04233-5

The role of adipose-derived stem cells in knee osteoarthritis ... Adipose mesenchymal stromal cell-based therapy for severe osteoarthritis of the knee: a phase I dose-escalation trial. Stem Cells Transl Med.

5. tandfonline.com tandfonline.com/doi/full/10.2217/rme-2018-0161

Adipose-Derived Mesenchymal Stem Cell Therapy in the ... Aim: To evaluate the efficacy of autologous adipose-derived mesenchymal stem cell (ADMSC) therapy on pain, function and disease modification in knee ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03513731

Safety of Adipose-derived Regenerative Cells Injection for ... Safety of Adipose-derived Regenerative Cells Injection for Treatment of Osteoarthritis of the Facet Joint. ClinicalTrials.gov ID NCT03513731. Sponsor InGeneron ...