What side effects are associated with this type of intervention?

Common treatments for osteoarthritis, such as NSAIDs (e.g., naproxen, ibuprofen, celecoxib), can cause gastrointestinal issues, cardiovascular risks, and renal problems. Glucocorticoids, used for short-term relief, may lead to systemic side effects like weight gain, osteoporosis, and increased infection risk. Investigational agents like tanezumab and fasinumab, which target nerve growth factor, have been associated with rapidly progressive OA, increased joint replacements, and nervous system effects. These side effects highlight the importance of careful management and monitoring by healthcare providers.

What prior FDA approvals exist?

The FDA has previously approved several treatments for osteoarthritis, including nonsteroidal anti-inflammatory drugs (NSAIDs) like naproxen, meloxicam, diclofenac, and ibuprofen, which are commonly used for pain relief. Additionally, intraarticular injections of corticosteroids and hyaluronic acid have been used, although their routine use is not always recommended. Anti-NGF agents such as tanezumab showed promise in clinical trials but were associated with safety concerns, including rapidly progressive osteoarthritis, leading to discontinuation of their development. Other investigational treatments, like fasinumab, also demonstrated efficacy but had higher rates of adverse effects, particularly in the nervous and musculoskeletal systems.

What other types of research exist?

Promising novel alternatives for osteoarthritis treatment in 2024 include: 1) Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs), which are being evaluated for their potential to improve pain, mobility, and daily function in OA patients. 2) Tropomyosin receptor kinase A (TrkA) inhibitors, such as GZ389988A, which have shown efficacy in reducing knee OA pain. 3) Intra-articular sprifermin, which has been associated with increased cartilage thickness, although its clinical relevance is still being studied. These treatments represent innovative approaches that may offer new options for OA management.

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Mesenchymal Stem Cells

AdMSCs for Osteoarthritis (AdMSCs Trial)

Phase 2

Waitlist Available

Led By Derek W Guillory, MD.

Research Sponsored by Celltex Therapeutics Corporation

Eligibility Criteria Checklist

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

Must have

Age above 18 years

Must be diagnosed as OA-knees, OA-hips, or OA-shoulders by radiographic criteria and physical examination.

Must not have

Previous thrombotic disorder

Irreversible severe end-organ failure, such as heart failure/attack, stroke, liver and renal failure due to other disease conditions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 month

Awards & highlights

No Placebo-Only Group

Summary

This trial involves testing a treatment for osteoarthritis in 300 patients with affected knees, hips, and shoulders. The study will measure symptoms like pain and mobility to evaluate the treatment's effectiveness. The goal is to see if the new treatment can improve daily life and joint function for these patients.

Who is the study for?

This trial is for adults over 18 with osteoarthritis in knees, hips, or shoulders confirmed by X-rays and physical exams. Participants must have their own AdMSCs banked at Celltex, having cleared tests for HIV, syphilis, Hepatitis B and C. They should be able to follow the study procedures and provide informed consent.

What is being tested?

The trial studies the effects of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) on osteoarthritis. It's a phase 2 study with six groups: one control and one treatment group for each joint category (knees, hips, shoulders), assessing pain relief and improved joint function.

What are the potential side effects?

Potential side effects may include reactions related to stem cell therapy such as inflammation at injection site or allergic reactions to culture components like BSA or DMSO used in AdMSC preparation.

Eligibility Criteria

Inclusion Criteria

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

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I am over 18 years old.

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I have been diagnosed with osteoarthritis in my knees, hips, or shoulders through X-rays and physical exams.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a blood clotting disorder in the past.

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I do not have severe damage to my heart, liver, or kidneys from other diseases.

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I understand the details and risks of the study.

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I have been using immunosuppressive drugs for a long time.

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I have not had an organ transplant in the last 6 months.

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I have not had major surgery or serious injury in the last 14 days.

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My cancer is currently active.

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I or my family have a history of blood clotting disorders.

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I have had a pulmonary embolism or have been diagnosed with anti-phospholipid syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Any organ damage or safety concerns determined by SMAC 20 blood test.

the frequency and nature of adverse events occurring during the study based on the annualized rate of all AdMSC-associated adverse events (AEs) in all subjects.

Secondary study objectives

Change of Constant shoulder score (CSS, 0 is the worst and 100 is the best) from the baseline for OA-shoulder patients

Change of Harris Hip Score (HHS, 0 is the worst and 100 is the best) from the baseline for OA-hip patients

Change of Hip disability and Osteoarthritis Outcome Score (HOOS, 0 is the worst and 100 is the best) from the baseline for OA-hip patients

+4 more

Other study objectives

Number of patient achieve Image (X-ray or MRI) improvement above 30%, 50% and 70% from the baseline

Pain

Awards & Highlights

No Placebo-Only Group

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

Trial Design

6Treatment groups

Experimental Treatment

Active Control

Group I: Phase 2 Arm 5 - OA ShoulderExperimental Treatment1 Intervention

50 subjects receive two doses of 2.0-2.86 x 10\^6 cells/kg on days 0 and 6 via intravenous infusion. On day 3, each subject will receive a single dose of 1.0-2.86 x 10\^6 cells/kg via intra-articular injection into the injured joint.

Group II: Phase 2 Arm 3 - OA HipExperimental Treatment1 Intervention

Group III: Phase 2 Arm 1 - OA KneeExperimental Treatment1 Intervention

Group IV: Phase 2 Arm 2 OA KneeActive Control1 Intervention

Control group- 50 subjects receive three doses of 2.0-2.86 x 10\^6 cells/kg on day 0, 3, and 6 via intravenous infusion

Group V: Phase 2 Arm 6 - OA ShoulderActive Control1 Intervention

Control group- 50 subjects receive three doses of 2.0-2.86 x 10\^6 cells/kg on day 0, 3, and 6 via intravenous infusion

Group VI: Phase 2 Arm 4 - OA HipActive Control1 Intervention

Control group- 50 subjects receive three doses of 2.0-2.86 x 10\^6 cells/kg on day 0, 3, and 6 via intravenous infusion

0 / 11Eligibility 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

Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen work by inhibiting cyclooxygenase enzymes (COX-1 and COX-2), reducing inflammation and pain. Glucocorticoids, such as prednisone, decrease inflammation by suppressing the immune response. Platelet-rich plasma (PRP) therapy aims to promote tissue repair by injecting concentrated platelets, although its efficacy is still under investigation. Gene therapy approaches, like TissueGene-C, involve modifying cells to produce growth factors that may help in cartilage repair. Understanding these mechanisms helps OA patients and their doctors choose the most appropriate treatment based on the specific pathways involved in their symptoms and disease progression.

Osteoarthritis of the knee - biochemical aspect of applied therapies: a review.