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Mandible TumorPhase 1/2EB-CMFNCT03678467

Evaluation of EpiBone-CMF for Mandibular Ramus Reconstruction

A Phase 1/2 study testing EB-CMF in people with Mandible Tumor and Mandibular Injuries, run by Epibone, Inc. at 3 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

EpiBone-Craniomaxillofacial (EB-CMF) is an autologous, anatomically shaped bone graft created specifically for the patient's defect, using the patients own adipose-derived mesenchymal stem cells. This first in human trial is designed specifically to assess the safety of EB-CMF clinically. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
EB-CMF
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
3 sitesUnited States
Study dates
31 Mar 2021to Nov 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
  • Stable mandibular ramus injury or defect due to trauma, disease, or congenital defects.
  • Medical history must be verified by either a personal physician or medical practitioner as appropriate.
  • Patient determined by the Investigator to be a suitable candidate by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac evaluation.
  • A female patient is eligible to participate if she is not pregnant (see Appendix 6), not breastfeeding, and at least 1 of the following conditions applies:
  • A woman of nonchildbearing potential (WONCBP) as defined in Appendix 6. OR
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  • A woman of childbearing potential (WOCBP) who agrees to follow the contraceptive guidance in Appendix 6 for at least 1 month prior to surgery, during the treatment period, and until 12 weeks after completion of the study.
  • Patient must be available at the study center for all specified assessments throughout the study duration.
  • Patients whose clinical laboratory test results are within the reference range for healthy individuals, or where outside the reference range is judged as not clinically relevant by the Investigator.
  • All patients are required to give written informed consent as described in Appendix 2, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol, and in accordance with the Declaration of Helsinki, before enrollment. Patients must provide written informed consent and authorization for use and disclosure of protected health information.
  • A healthy condyle which can be plated with titanium plates and screws.
  • A mandibular continuity ramus defect which starts below the sigmoid notch and extends only as far as but not including the angle.

Who cannot join

  • Uncontrolled alcohol, tobacco, or substance abuse within 6 months prior to implantation.
  • Mandibular ramus defects with open wounds.
  • Defects > 15 cc in volume.
  • Defects > 6 cm in diameter.
  • Systemic disease that would render the fat harvest and product implantation, along with associated anesthesia, unsafe to the patient.
  • Patient has any underlying or current medical or psychiatric condition that, in the opinion of the Investigator, would impact patient safety or interfere with the integrity of the study data.
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  • Active uncontrolled infection or malignancy. Patients will be allowed to undergo rescreening once, after the infection is cleared, if they are willing to do so.
  • Patients with signs and symptoms of infection between Screening and up to the surgical implantation.
  • Radiation therapy < 6 months prior to the surgical implantation.
  • Need for soft tissue reconstruction (flap, skin graft, etc).
  • Conditions that may impact the success of the surgical implantation or increase the risk of postoperative complications, including inherited coagulopathies like hemophilia, Von Willebrand's disease, protein C and S deficiency, thrombocythemias, thallassemias, sickle cell disease, etc.
  • Conditions that may impact functional outcomes, including uncontrolled diabetes, osteoporosis, rare disorders of bone healing like osteopetrosis, or any other metabolic bone disease.
  • Increased alkaline phosphatase (to exclude Paget's disease), increased serum calcium (to exclude hyperparathyroidism), or Vitamin D deficiency, at Screening, confirmed by a repeat test.
  • Oral bisphosphonate < 12 weeks, intravenous bisphosphonate < 12 months prior to Screening or use of systemic steroids or anabolic agents (e.g. teriparatide) for osteoporosis treatment.
  • Patients with inadequate donor sites for lipoaspirate of adipose tissue.
  • Mixed connective tissue diseases and collagen diseases which can result in poor wound healing after surgery.
  • Patients considered unsuitable per the consulted surgeon.
  • Patient has any of the following conditions as identified by medical history:
  • Human immunodeficiency virus (active or seropositive).
  • Active tuberculosis.
  • Active hepatitis B infection.
  • Hepatitis C.
  • Viral encephalitis.
  • Toxoplasmosis. In case of doubt regarding mentioned conditions based on the physical examination or other signs or symptoms present at Screening, the patient will be asked to consent to additional testing to rule out such conditions or the patient must be excluded from the study.
  • Donation of blood and blood products is not permitted from Screening and for at least 3 months after the surgical implantation.
  • Patient participated in another clinical study of an investigational drug within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior to the surgical implantation or is currently participating in another clinical study of an investigational drug or intending to participate in another clinical study of an investigational drug before completion of all scheduled evaluations in this clinical study.
  • Patients who, in the opinion of the Investigator, are not likely to complete the study for whatever reason.
  • The Investigator or any sub-investigator, research assistant, surgeon, study coordinator, or other staff directly involved in the conduct of the clinical study or any of their relatives.
  • Hypersensitivity to any product of bovine origin.
  • Hypersensitivity to gentamicin or other aminoglycosides.
  • Post-menopausal women who have an abnormally low bone mineral density or have not tested for bone mineral density.
  • Patients with discontinuity defects of the ramus.
  • Patients with a history of malignant cancer.
  • Hypersensitivity or allergy to epinephrine or other drugs commonly used during surgery.

Trial locations and contacts

3 sites in 1 country.

Brian R Gastman, MD contact

216-444-9419

gastmab@ccf.org

United States3 sites, 3 recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Beverly Doyle

    Recruiting

  • UT Health San Antonio

    San Antonio, Texas, 78229

    Erin Locke, BSN, RN

    Recruiting

  • VA Healthcare System, San Francisco

    San Francisco, California, 94121

    Rebeka Silva, DMD, FACD

    Recruiting

Other trials in United States

About this study

Official title: An Open-Label, First-in-Human, Single Intervention Study for Evaluation of EpiBone-CMF Engineered Living Bone Graft for Mandibular Ramus Reconstruction

EpiBone-Craniomaxillofacial (EB-CMF) is an autologous, anatomically shaped bone graft created specifically for the patient's defect, using the patients own adipose-derived mesenchymal stem cells. This first in human trial is designed specifically to assess the safety of EB-CMF clinically. Although secondary measures of graft efficacy are being assessed, the primary focus will be on Adverse Events stemming from graft implantation.

Being tested
EB-CMF
Keywords
tissue engineering, tissue engineered product, mesenchymal stem cells
Medical subject headings
Mandibular Neoplasms, Mandibular Injuries, Congenital Abnormalities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EB-CMFCombination product

    Autologous, anatomically shaped bone graft

Study groups in NCT03678467
Study groupRoleWhat they receive
EB-CMF ImplantExperimentalSubject receiving EB-CMF implant
Receives: Combination Product: EB-CMF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with treatment-related adverse events

    To assess the safety of EB-CMF for up to 12 months post surgery in subjects with recent or remote mandibular ramus defects requiring up to a 15 cc graft reconstruction.

    Measured: 12 months

Secondary outcomes (3)

  1. Bone regeneration as assessed by high-resolution CT scans

    To assess the efficacy of the EpiBone-CMF graft for up to 12 months post-surgery in subjects with recent or remote mandibular ramus defects requiring up to a 15 cc graft reconstruction. Bone regeneration as assessed by high-resolution CT scans for up to 12 months post-surgery.

    Measured: 12 months

  2. Quality of life as measured by the Glasgow Benefit Inventory

    To assess the changes in quality of life for up to 12 months post-surgery in patients as measured by the Glasgow Benefit Inventory.

    Measured: 12 months

  3. Quality of life as measured by SF-12

    To assess the changes in quality of life for up to 12 months post-surgery in patients as measured by SF-12.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2018
  2. Study start31 Mar 2021
  3. Primary completionAug 2023 (estimated)
  4. Study completionNov 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03678467
Sponsor's protocol ID
EB-CMF-02
Acronym
EB-CMF
Status last verified
May 2022
First submitted
12 Sep 2018
Last updated
27 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
Yes

Publications

  • Bhumiratana S, Bernhard JC, Alfi DM, Yeager K, Eton RE, Bova J, Shah F, Gimble JM, Lopez MJ, Eisig SB, Vunjak-Novakovic G. Tissue-engineered autologous grafts for facial bone reconstruction. Sci Transl Med. 2016 Jun 15;8(343):343ra83. doi: 10.1126/scitranslmed.aad5904.

    PubMed 27306665

  • Bhumiratana S, Vunjak-Novakovic G. Concise review: personalized human bone grafts for reconstructing head and face. Stem Cells Transl Med. 2012 Jan;1(1):64-9. doi: 10.5966/sctm.2011-0020. Epub 2011 Dec 7.

    PubMed 23197642

  • Grayson WL, Marolt D, Bhumiratana S, Frohlich M, Guo XE, Vunjak-Novakovic G. Optimizing the medium perfusion rate in bone tissue engineering bioreactors. Biotechnol Bioeng. 2011 May;108(5):1159-70. doi: 10.1002/bit.23024. Epub 2010 Dec 22.

    PubMed 21449028

  • Grayson WL, Bhumiratana S, Cannizzaro C, Vunjak-Novakovic G. Bioreactor cultivation of functional bone grafts. Methods Mol Biol. 2011;698:231-41. doi: 10.1007/978-1-60761-999-4_18.

    PubMed 21431523

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing EB-CMF in people with Mandible Tumor and Mandibular Injuries, run by Epibone, Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Brian R Gastman, MD (216-444-9419, gastmab@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with treatment-related adverse events (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03678467, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.

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