← Back to Search

Immunomodulatory Protocol

Face Transplant for Facial Disfigurement

Phase 2

Recruiting

Led By Damon Cooney, MD, PHD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

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

Must have

Aged 18-65 years

Strong desire to undergo craniomaxillofacial transplantation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up transplantation to end of study period (up to 5 years)

Awards & highlights

Study Summary

This trial will document the use of a new immunomodulatory protocol for establishing face transplantation as a safe and effective reconstructive treatment for devastating injuries/ defects.

Who is the study for?

This trial is for adults aged 18-65 with severe facial injuries or defects, who are non-smokers and U.S. citizens or equivalent. They must not have psycho-social issues like drug abuse, active cancer in the past 5 years, or conditions affecting treatment outcomes. Women of childbearing age should agree to use contraception for a year post-transplant.Check my eligibility

What is being tested?

The study tests a new protocol combining bone marrow cell therapy with low-dose immunosuppression (1-drug) to minimize side effects after face transplantation. It aims to safely restore facial function and appearance using fewer drugs over time.See study design

What are the potential side effects?

Potential side effects include infection risks due to lowered immunity from immunosuppressive drugs, possible metabolic issues, and an increased chance of developing certain cancers as a result of long-term immunosuppression.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18 and 65 years old.

Select...

I strongly want to have face and skull surgery.

Select...

I have been cancer-free for the last 5 years.

Select...

I agree to have my cells collected, stored, and infused back into my bone marrow.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ transplantation to end of study period (up to 5 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~transplantation to end of study period (up to 5 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and transplantation to end of study period (up to 5 years) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Graft Survival

Secondary outcome measures

Documentation of immunosuppression required by transplanted participants to maintain graft.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (Transplantation)Experimental Treatment1 Intervention

Face transplantation in combination with a novel donor bone marrow cell-based therapy followed by single-drug immunosuppression with potential weaning.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,268 Previous Clinical Trials

14,838,392 Total Patients Enrolled

Damon Cooney, MD, PHDPrincipal InvestigatorJohns Hopkins University

Media Library

Pittsburgh Protocol/Starzl Protocol (Immunomodulatory Protocol) Clinical Trial Eligibility Overview. Trial Name: NCT01889381 — Phase 2

Facial Injuries Research Study Groups: Treatment (Transplantation)

Facial Injuries Clinical Trial 2023: Pittsburgh Protocol/Starzl Protocol Highlights & Side Effects. Trial Name: NCT01889381 — Phase 2

Pittsburgh Protocol/Starzl Protocol (Immunomodulatory Protocol) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01889381 — Phase 2

Frequently Asked Questions

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

Has the FDA sanctioned bone marrow cell-based therapy coupled with single drug immunosuppression?

"The safety of bone marrow cell-based therapy and one drug immunosuppression has been estimated to be a 2 out of 3, given that the trial is in its second phase with limited data regarding efficacy."

Answered by AI

Is there an age cap when it comes to enrolment for this research endeavor?

"According to the screening criteria, individuals aged 18-65 are eligible for this trial. For those under 18 or over 65 years of age there are an additional 181 and 685 trials respectively available."

Answered by AI

What is the cohort size for this research investigation?

"That is correct. According to the information present on clinicaltrials.gov, this medical experiment is actively seeking out participants and was first posted on August 1st 2012 with its most recent update taking place on August 1st 2022. As of now, 15 individuals are required from a single location."

Answered by AI

Would I be eligible to join this medical experiment?

"This medical trial requires 15 participants aged between 18 and 65 to have sustained a craniomaxillofacial injury, either recently or in the distant past. Eligibility criteria include being of any gender or ethnicity, never having smoked tobacco products or quitting 6 months prior to screening, and not suffering from any additional medical conditions that would impede the procedure's success."

Answered by AI

Is this experimentation still accepting participants?

"Affirmative. According to clinicaltrials.gov, this medical investigation is presently recruiting patients who meet the criteria for inclusion. This trial began on August 1st 2012 and has been updated most recently on August 1st 2022; it requires 15 participants at a single site."

Answered by AI

Recent research and studies

Annals of SurgeryJournal

Upper-extremity Transplantation Using a Cell-based Protocol to Minimize Immunosuppression

Schneeberger, Stefan, Vijay S. Gorantla, Gerald Brandacher, Adriana Zeevi, Anthony J. Demetris, John G. Lunz, Diana M. Metes, et al.. 2013. “Upper-extremity Transplantation Using a Cell-based Protocol to Minimize Immunosuppression”. Annals of Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/sla.0b013e31826d90bb.

clinicaltrials.govStudy

Human Craniomaxillofacial Allotransplantation

2012. "Human Craniomaxillofacial Allotransplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01889381.

All > Paid Studies Maryland