CTM Boost or PRP for Shoulder Pain

(CTM RCT Trial)

Not currently recruiting at 4 trial locations

Overseen By Sarah Kimutis

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Disqualifiers: Adhesive capsulitis, Joint instability, others

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

Prior Safety Data This treatment has passed at least one previous human trial

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 explores two treatments to determine which better eases shoulder pain from rotator cuff tendinopathy, a condition where shoulder tendons become irritated or damaged. Participants will receive a single injection of either CTM Boost (a human placental connective tissue matrix) or platelet-rich plasma (PRP) to compare their effectiveness. It suits anyone with rotator cuff tendinopathy who has been advised by a doctor to try one of these injections and is open to receiving it. As a Phase 4 trial, the treatments have already received FDA approval and proven effective, and this research aims to understand how they benefit more patients.

Will I have to stop taking my current medications?

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.

What is the safety track record for these treatments?

Research has shown that both CTM Boost and PRP treatments are generally safe for people.

CTM Boost uses a special tissue from the placenta that flows easily. Studies suggest it aids healing without requiring surgery or causing major disruption to the body. Although specific safety data is limited, the treatment's design suggests it is well-tolerated.

PRP therapy uses components of a person's own blood, reducing the risk of adverse reactions. Studies have found it safe, with most reporting no serious side effects. Some individuals might experience minor discomfort at the injection site, which is common with any joint injection.

Both treatments aim to address rotator cuff problems without major safety concerns. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about CTM Boost and PRP treatments for shoulder pain because they offer innovative approaches compared to traditional options like physical therapy, corticosteroid injections, or surgery. CTM Boost is distinctive because it involves a direct injection of a unique compound into the rotator cuff, potentially providing targeted relief and promoting tissue healing in ways standard treatments do not. PRP, on the other hand, uses the body's own platelet-rich plasma to accelerate recovery, harnessing natural growth factors to repair damaged tissues. Both approaches focus on enhancing the body's healing processes, which could lead to faster recovery times and improved outcomes for patients.

What evidence suggests that this trial's treatments could be effective for rotator cuff tendinopathy?

Research has shown that Platelet-Rich Plasma (PRP) injections, one of the treatments in this trial, can reduce pain and improve shoulder movement in people with rotator cuff injuries. Studies indicate that PRP offers better long-term results than some steroid treatments and aids in tendon healing. In contrast, Connective Tissue Matrix (CTM) Boost, another treatment option in this trial, is believed to support tendon healing by promoting tissue repair. Early research suggests that CTM Boost might be effective for people with rotator cuff problems, but more information is needed to confirm this. Both treatments in this trial aim to improve symptoms and facilitate rotator cuff healing. ^{1 2 4 5 6}

Who Is on the Research Team?

Patrick Demeo, MD

Principal Investigator

Allegheny Health Network

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with rotator cuff tendinopathy who are deemed suitable for PRP or CTM-type injection treatments. It's not open to those with certain shoulder conditions, a history of recent shoulder surgery or injections, or medical issues affecting healing like severe kidney disease or uncontrolled diabetes.

Inclusion Criteria

My doctor recommends a PRP or CTM injection, and I agree to have it.

Exclusion Criteria

I do not have conditions like severe kidney disease or uncontrolled diabetes that could affect healing.

I have not had shoulder surgery or steroid injections in the last 3 months.

I have been diagnosed with frozen shoulder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single injection of either CTM Boost or PRP directly into the rotator cuff

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6 months

6 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• CTM Boost
• PRP

Trial Overview The study is testing the effectiveness of a single CTM Boost injection compared to a single platelet rich plasma (PRP) injection in reducing symptoms of rotator cuff tendinopathy. Participants will receive one of these treatments based on what their doctor thinks is best.

How Is the Trial Designed?

Group I: CTM Treatment Experimental Treatment 1 Intervention

2.0 cc (cubic centimeter) dose injection of CTM Boost will be administered by injection directly into the rotator cuff using a 20 gauge needle.

Group II: PRP Treatment Active Control 1 Intervention

Each participant randomized to this arm will receive a single injection of Platelet Rich Plasma (PRP).

CTM Boost is already approved in United States for the following indications:

Approved in United States as CTM Boost for:

• Rotator cuff tendinopathy

Who Is Running the Clinical Trial?

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Lead Sponsor

Trials

52

Recruited

13,000+

Connective Tissue Matrix Biomedical, LLC

Collaborator

Trials

1

Recruited

90+

Published Research Related to This Trial

In a study involving 95 patients with carpometacarpal arthritis of the thumb, the combination of autologous fat and platelet-rich plasma (PRP) significantly reduced pain compared to saline, indicating its efficacy as a treatment option.

This combination therapy not only alleviated pain but also improved hand function and quality of life, making it a safe alternative to short-acting glucocorticoids, with no major complications reported over a 2-year follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimally Invasive Treatment of Trapeziometacarpal Osteoarthritis: Results of a Blinded Randomized Controlled Trial. Winter, R., Tuca, AC., Justich, I., et al.[2023]

In a study involving 44 Wistar rats, the injection of autologous platelet-rich plasma (PRP) after rotator cuff repair significantly improved tendon strength and stiffness compared to controls, indicating enhanced healing.

Histological analysis showed that PRP-treated tendons had better collagen organization and higher Bonar scores, suggesting improved tissue quality, although vascularity was similar between both groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A single dose of platelet-rich plasma improves the organization and strength of a surgically repaired rotator cuff tendon in rats. Dolkart, O., Chechik, O., Zarfati, Y., et al.[2019]

In a study of 76 patients undergoing arthroscopic rotator cuff repair, the use of autologous platelet-rich plasma in fibrin matrix (PRPFM) did not show any significant improvement in clinical outcomes compared to the control group, as measured by the Western Ontario Rotator Cuff (WORC) scores and Simple Shoulder Test.

The rate of retear was lower in the PRPFM group (7.4%) compared to the control group (19%) at 6 months, but overall, the results were statistically insignificant, indicating that PRPFM may not provide a clear benefit in tendon healing for rotator cuff repairs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet-rich plasma in fibrin matrix to augment rotator cuff repair: a prospective, single-blinded, randomized study with 2-year follow-up. Walsh, MR., Nelson, BJ., Braman, JP., et al.[2018]

In a randomized controlled trial involving 99 patients with partial-thickness rotator cuff tears, those receiving platelet-rich plasma (PRP) injections showed significantly greater short-term improvements in pain and function at 3 months compared to those receiving corticosteroid (CS) injections.

However, by 12 months, there were no significant differences in pain relief or functional outcomes between the PRP and CS groups, indicating that while PRP may offer short-term benefits, it does not provide sustained advantages over corticosteroids in the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet-Rich Plasma in Patients With Partial-Thickness Rotator Cuff Tears or Tendinopathy Leads to Significantly Improved Short-Term Pain Relief and Function Compared With Corticosteroid Injection: A Double-Blind Randomized Controlled Trial. Kwong, CA., Woodmass, JM., Gusnowski, EM., et al.[2021]

Platelet-rich plasma (PRP) injections have shown positive effects in treating partial thickness rotator cuff tears (PTRCTs) in patients over 50, improving pain, function, and shoulder joint range of motion.

PRP is considered a safe and easy-to-prepare treatment option, making it a viable conservative management strategy for PTRCTs, especially given the controversy surrounding surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Results of Platelet-Rich Plasma for Partial Thickness Rotator Cuff Tears: A Case Series. Zafarani, Z., Mirzaee, F., Guity, M., et al.[2020]

In a study of 71 patients with moderate carpal tunnel syndrome (CTS) receiving platelet-rich plasma (PRP) injections, lower baseline body weight, distal motor latency, and cross-sectional area of the median nerve were associated with better outcomes at 3 and 6 months post-injection.

The study identified specific predictive factors for the efficacy of PRP injections, suggesting that patients with these characteristics may experience greater relief from CTS symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome predictors of platelet-rich plasma injection for moderate carpal tunnel syndrome. Shen, YP., Li, TY., Chou, YC., et al.[2021]

In a study of 69 patients undergoing rotator cuff repair, the use of autologous platelet-rich plasma (PRP) gel showed a trend towards improved healing and clinical outcomes compared to a control group, although these results were not statistically significant at the final follow-up.

At the 3-month mark, patients receiving PRP gel demonstrated significantly better clinical results, suggesting that PRP may enhance early recovery, but overall healing rates on MRI were similar between the two groups after 24 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic knotless tape bridging with autologous platelet-rich fibrin gel augmentation: functional and structural results. Dukan, R., Bommier, A., Rousseau, MA., et al.[2022]

In a study of 50 patients with partial rotator cuff tears, subacromial platelet-rich plasma (ACP) injections showed earlier improvements in shoulder function and pain relief compared to standard cortisone injections, particularly noticeable at 12 weeks post-injection.

While both treatments improved MRI findings of tendinopathy, the ACP group had significantly better outcomes on pain and shoulder assessment scales at 12 weeks, making ACP a viable alternative for patients who cannot receive cortisone injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of subacromial injections of autologous conditioned plasma versus cortisone for the treatment of symptomatic partial rotator cuff tears. von Wehren, L., Blanke, F., Todorov, A., et al.[2018]

Citations

1. 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06160427

NCT06160427 | Connective Tissue Matrix for Rotator Cuff ... 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 ...

3. 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 ...

4. biolscigroup.us biolscigroup.us/articles/JBM-6-130.pdf

Flowable placental connective tissue matrices for tendon repair The outcome and repair integrity of completely arthroscopically repaired large and massive rotator cuff tears. J Bone Joint Surg Am. 2004;86 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9294091/

A decellularized flowable placental connective tissue ... Injectable connective tissue matrices (CTMs) may promote tendon healing, given their minimally invasive properties, structural and ...

6. trialx.com trialx.com/clinical-trials/listings/321648/connective-tissue-matrix-compared-to-steroid-injections-for-rotator-cuff-tendinopathy/

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 boost ...