Stem Cell Injection for Osteoarthritis

Recruiting at 1 trial location

Overseen By Claire Huang, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: InGeneron, Inc.

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

Disqualifiers: Pregnancy, Obesity, Active malignancy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug for osteoarthritis?

Research shows that intra-articular injections of triamcinolone hexacetonide, a type of corticosteroid, can improve symptoms in knee osteoarthritis, with some studies indicating it may be more effective than other corticosteroids like methylprednisolone. ^{1 2 3 4 5}

Is stem cell injection for osteoarthritis safe?

The safety of corticosteroid injections, which are sometimes used in similar contexts, has been studied, showing potential side effects like skin thinning and hormonal imbalances. However, specific safety data for adipose-derived stem cell injections for osteoarthritis is not provided in the available research. ^{6 7 8 9 10}

How is the stem cell injection treatment for osteoarthritis different from other treatments?

The stem cell injection treatment for osteoarthritis is unique because it uses adipose-derived stem cells (from fat tissue) to potentially regenerate damaged joint tissue, unlike traditional treatments like corticosteroids that mainly focus on reducing inflammation and pain. This approach aims to address the underlying cause of joint degeneration rather than just alleviating symptoms. ^{2 3 11 12 13}

Research Team

Thomas Boetel, MD

Principal Investigator

Sanford Health

Eligibility Criteria

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

I am between 18 and 75 years old.

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

I have been diagnosed with symptomatic facet joint syndrome.

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.

Trial Timeline

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

Treatment Details

Interventions

• Adipose-derived stem cell injection (Stem Cell Therapy)
• Corticosteroid injection (Corticosteroid)

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.

Participant Groups

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 Canada for the following indications:

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+

Findings from Research

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 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 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]

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 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]

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]

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]

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 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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

A thermographic and clinical comparison of three intra-articular steroid preparations in rheumatoid arthritis. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

Efficacy of Triamcinolone Hexacetonide versus Methylprednisolone Acetate Intraarticular Injections in Knee Osteoarthritis: A Randomized, Double-blinded, 24-week Study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Randomised controlled study of postinjection immobilisation after intra-articular glucocorticoid treatment for wrist synovitis. [2019]

4. United States 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. [2023]

5. Norway pubmed.ncbi.nlm.nih.gov

Intra-articular glucocorticoids in early juvenile chronic arthritis. [2019]

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

Risk of serious spinal adverse events associated with epidural corticosteroid injections in the Medicare population. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Autologous fat transplantation for multiple scattered steroid atrophy and hypopigmentation: A case report. [2023]

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

Reversal of steroid-induced lipoatrophy with serial injections of isotonic saline in a child. [2021]

9. Egypt pubmed.ncbi.nlm.nih.gov

Iatrogenic cushing syndrome secondary to ritonavir-epidural triamcinolone interaction: an illustrative case and review. [2021]

10. Korea (South) 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. [2022]

11. United States 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. [2022]

12. Switzerland 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. [2022]

13. New Zealand pubmed.ncbi.nlm.nih.gov

Triamcinolone Acetonide Extended-Release: A Review in Osteoarthritis Pain of the Knee. [2023]