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Biologic Scaffold Material

MatriStem PSM for Esophageal Cancer

Phase 2

Waitlist Available

Led By Vivian Strong, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days post op

Awards & highlights

Study Summary

This trial will test whether MatriStem can lower the risk of a common complication after surgery for stomach or esophagus cancer.

Eligible Conditions

Esophageal Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days post op

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days post op

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days post op for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With Anastomotic Leak.

Secondary outcome measures

Number of Participants Who Developed Anastomotic Stenosis

Stricture Formation Clinically and by Determination of Dysphagia Score

Side effects data

From 2023 Phase 2 trial • 78 Patients • NCT01970306

Esophageal anastomotic leak

Stomach pain

Esophageal stenosis

Atrial fibrillation

Respiratory failure

Dysphagia

Pleural effusion

Tracheal fistula

Abdominal pain

Ventricular arrhythmia

Ileus

Gastric anastomotic leak

Wound infection

Pneumothorax

Diarrhea

Lung infection

Myocardial infarction

Gastric necrosis

Hepatic infection

Death NOS

Heart failure

Acute kidney injury

100%

80%

60%

40%

20%

Study treatment Arm

Surgical Intervention

Trial Design

1Treatment groups

Experimental Treatment

Group I: Surgical interventionExperimental Treatment1 Intervention

Patients will undergo standard resection and gastrointestinal anastomosis and will then have reinforcement of the anastomosis with MatriStem PSM. Patients undergoing esophagectomy, PG or TG will be evaluated with one routine postoperative contrast swallow study at post-operative day #4-10.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MatriStem PSM

2013

Completed Phase 2

~80

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Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,814 Total Patients Enrolled

Integra LifeSciences CorporationIndustry Sponsor

84 Previous Clinical Trials

9,411 Total Patients Enrolled

Vivian Strong, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

1 Previous Clinical Trials

10 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the regulatory status of MatriStem PSM?

"Due to the lack of efficacy data, MatriStem PSM received a score of 2 on our team's safety scale. However, there is evidence supporting its security from Phase 2 trials."

Answered by AI

Is this clinical inquiry accepting fresh participants?

"According to the data available on clinicaltrials.gov, this specific medical trial is not presently accepting new applications for participation. The experiment was initially posted in 2013 and last updated in 2022; however, there are an additional 777 trials actively searching for participants at present."

Answered by AI

Are there any US locations which have been approved to host this experiment?

"There are 4 prominent medical centres currently recruiting patients for this clinical trial, with Memorial Sloan Kettering Cancer Centers located in Basking Ridge, Harrison and New york. Additionally, other sites across the USA are also participating in this study."

Answered by AI

Recent research and studies

Journal of the American College of SurgeonsJournal

Phase II Trial Evaluating Esophageal Anastomotic Reinforcement with a Biologic, Degradable, Extracellular Matrix After Total Gastrectomy and Esophagectomy

Vos, Elvira L, Masaya Nakauchi, Marinela Capanu, Bernard J Park, Daniel G Coit, Daniela Molena, Samuel S Yoon, David R Jones, and Vivian E Strong. 2022. “Phase II Trial Evaluating Esophageal Anastomotic Reinforcement with a Biologic, Degradable, Extracellular Matrix After Total Gastrectomy and Esophagectomy”. Journal of the American College of Surgeons. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/xcs.0000000000000113.

Journal of the American College of SurgeonsJournal

Validated Risk-score Model Predicting Lymph Node Metastases in Patients with Non-functional Gastroenteropancreatic Neuroendocrine Tumors

Shannon, Adrienne B, Richard J Straker, Douglas L Fraker, John T Miura, and Giorgos C Karakousis. 2022. “Validated Risk-score Model Predicting Lymph Node Metastases in Patients with Non-functional Gastroenteropancreatic Neuroendocrine Tumors”. Journal of the American College of Surgeons. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/xcs.0000000000000144.

clinicaltrials.govStudy

Evaluate Esophageal Reinforcement With ACell MatriStem Surgical Matrix: A Degradable Biologic Scaffold Material

2013. "Evaluate Esophageal Reinforcement With ACell MatriStem Surgical Matrix: A Degradable Biologic Scaffold Material". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01970306.