CTM Injection for Shoulder Osteoarthritis

(HC22-1 Trial)

Overseen By Lexie Reissaus

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Indiana Hand to Shoulder Center

Disqualifiers: Inflammatory arthritis, Brachial plexopathy, Cervical spine abnormalities, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for shoulder osteoarthritis, a condition that wears down the shoulder joint and causes pain. The treatment involves a single injection of a special tissue product (CTM injection) into the shoulder joint to determine if it can reduce pain and improve shoulder function over time. Researchers will observe its effectiveness and whether certain factors might predict the need for further treatment. Individuals diagnosed with shoulder osteoarthritis and experiencing pain might be suitable candidates for this study. As a Phase 1 trial, this 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 for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Past studies have generally found CTM injections to be safe. For example, research on CTM for thumb arthritis and shoulder issues showed few serious side effects. Most patients experienced only mild, short-term pain at the injection site, a common occurrence with many injections.

Since this trial is in an early stage, the main goal is to ensure the treatment's safety. Researchers are closely monitoring any side effects. Although CTM products are used in other medical areas, suggesting potential safety, this specific use is still under careful study for confirmation. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for shoulder osteoarthritis, such as NSAIDs, corticosteroid injections, or physical therapy, the CTM Injection introduces a novel approach. Researchers are excited about this treatment because it may offer a new mechanism of action that targets the underlying causes of inflammation in the joint. Unlike conventional methods that focus mainly on symptom relief, CTM Injection could potentially modify the disease process itself, offering longer-lasting relief and improved joint function. This new method of addressing shoulder osteoarthritis could revolutionize how we manage the condition, providing hope for those who have not found success with existing treatments.

What evidence suggests that CTM Injection might be an effective treatment for shoulder osteoarthritis?

Research has shown that CTM injections, which use material from human placental tissue, aim to repair and support damaged shoulder tissue. In studies, patients who received CTM injections experienced significant improvements in pain and shoulder function. One study found that 83% of patients were very satisfied with their shoulder condition after the treatment. Although the current trial is still studying this treatment, early results suggest it could effectively reduce pain and improve movement for people with shoulder osteoarthritis. This promising evidence supports further research into CTM injections as a possible treatment option. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with shoulder osteoarthritis confirmed by X-rays. Participants will receive a single CTM injection guided by imaging to help with their condition. The study aims to track pain relief and improved shoulder function over time.

Inclusion Criteria

Patients who are able keep up regular communication through phone calls or electronic PROs

Patients who can consent to be a part of this study

I am getting a CTM injection as my first treatment.

Exclusion Criteria

I have nerve damage in my shoulder.

Those unable to keep up monthly communication through phone calls and/or electronic PROs

I have inflammatory arthritis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single image-guided injection of CTM for glenohumeral arthritis

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment at intervals of 1, 2, 3, 4, 6, 9, and 12 months

12 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• CTM Injection

Trial Overview The trial tests the effectiveness of a human placental connective-tissue matrix (CTM) injection in managing shoulder osteoarthritis. Success rates are measured using pain and shoulder function scores at multiple intervals up to one year post-injection.

How Is the Trial Designed?

Group I: CTM Shoulder Injection Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Indiana Hand to Shoulder Center

Lead Sponsor

Trials

9

Recruited

320+

CTM Biomedical

Industry Sponsor

Trials

5

Recruited

200+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06171542

Efficacy of a Single Image Guided Injection of CTM for ... A recent prospective study by our center identified a clinically meaningful and statistical improvement after corticosteroid injection in the Oxford Shoulder ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10532945/

Efficacy and Long-Term Outcomes of Intra-Articular ... The SANE results at 36 months were ≤60% (unsatisfactory outcome) for 5 patients (7.69%), ≥80% (complete satisfaction) for 54 patients (83.08%), ...

3. trials.arthritis.org trials.arthritis.org/trials/NCT06171529

Efficacy of a Single Injection of CTM for Post-Operative CMC ... The goal of this study is to determine the success rate of a single Carpometacarpal (CMC) thumb injection after arthroplasty surgery for primary osteoarthritis ...

4. withpower.com withpower.com/trial/phase-1-osteoarthritis-of-the-shoulder-11-2022-2b6a5

CTM Injection for Shoulder Osteoarthritis (HC22-1 Trial) The goal of this study is to determine the success rate of a single, image guided glenohumeral CTM injection (for radiographically confirmed glenohumeral ...

5. app.trialscreen.org app.trialscreen.org/trials/phase-1-efficacy-single-image-guided-injection-ctm-glenohumeral-arthritis-trial-nct06171542

Efficacy of a Single Image Guided Injection of CTM for ... Image-guided CTM injections use a substance derived from human placental connective tissue to support and mend damaged tissue in the shoulder.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06712290

Connective Tissue Matrix Compared to Steroid Injections ... The goal of the study is to see which is better at treating patients which rotator cuff tendinopathy (RCT): a single injection of Connective Tissue Matrix ...

7. trials.arthritis.org trials.arthritis.org/trials/NCT06160427

Connective Tissue Matrix for Rotator Cuff Tendinopathy The purpose of this research study is to determine if the effectiveness of a single injection of CTM Boost in the treatment of patients with rotator cuff ...