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Tibial FracturesPhase 3NCT03826784

Bone Healing Accelerant Versus Standard of Care for Open Tibia Fractures

A Phase 3 study testing BHA in people with Tibial Fractures, run by Carmell Therapeutics Corporation at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This clinical study is being conducted to demonstrate the safety and effectiveness of the Bone Healing Accelerant (BHA) product when applied to tibia (leg bone) fractures with an external wound or skin break (also called open tibia fractures). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Tibial Fractures
What is being tested?
BHA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Nov 2019to Feb 2022
Phase
Phase 3
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • In order to be eligible to participate in this study, subjects must meet all of the following criteria:
  • Patient is between the ages of 18-75 inclusive at time of randomization.
  • Patient has an acute open Gustilo-Anderson Type IIIA or IIIB fracture of the tibia shaft, with or without a fibula fracture, secondary to trauma.
  • Patient received antibiotic treatment within 2 hours of presentation at initial medical facility.
  • Patient underwent their first operative debridement within 24 hours of presentation at initial medical facility.
  • Patient is scheduled to have DWC within 14 days of initial injury.
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  • The tibia fracture requires open fracture reduction and internal fixation with intramedullary (IM) nailing;
  • IM nailing has been cross-locked for stability with a 4-5mm interlock, with a minimum of 1 static screw above the fracture site and 1 static screw below the fracture site, and
  • All IM nails have a diameter between 8.5-12mm with 1.0-1.5mm over-reaming of the canal.
  • The temporary use of external fixation prior to IM rodding and DWC is allowed.
  • Upon stabilization of the tibia fracture, the patient has a cortical deficit of less than or equal to 1.0cm involving no more than 50% of the tibia circumference. The cortical deficit of the residual 50% circumference must be less than 1.0cm. Gap assessments to be made with calibrated radiographs or visual inspection. In addition, patients are not likely to require a secondary procedure(s) to promote bone healing.
  • BHA is able to be applied through existing soft tissue defects created by the injury or those created during surgical treatment. No new incisions should be required specifically for application of BHA.
  • Patient is willing and able to comply with all study procedures including all pre-operative, post-operative and rehabilitation requirements.
  • Patient is able to give voluntary IC to participate and has signed an IC form specific to this study prior to study treatment and DWC.
  • Patients of childbearing potential must use adequate methods of contraception during the duration of follow-up (12-months). Adequate methods include abstinence, female and male sterilization, hormonal contraceptives, intrauterine devices (IUDs), implants, injectables, and double barrier methods.

Who cannot join

  • Patients who are currently participating in another investigational trial or having participated in a clinical investigation within the last 90 days or intend to during the course of the study.
  • Patients who are currently prisoners.
  • Patients who are unable to give informed consent.
  • Patients who are skeletally immature (<18 years of age or radiographic evidence of open tibial physes).
  • Patients with Type I, II, or IIIC open tibia fractures according to the Gustilo-Anderson classification.
  • Current injury is a pathological fracture.
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  • Patients with additional injuries that could impact their ability to complete the required assessments and postoperative rehabilitation. Examples include but are not limited to the following:
  • Head injury with impaired cognitive function,
  • Spinal injury with resultant neurologic weakness or paralysis,
  • Multi-trauma requiring prolonged hospitalization or recovery that, in the opinion of the investigator, the treatment and/or rehabilitation of such injuries will substantially interfere with the treatment, rehabilitation or other requirements outlined in this protocol,
  • Concomitant ipsilateral or contralateral lower extremity injury/fracture(s) if, in the opinion of the investigator, the treatment and/or rehabilitation of such fracture(s) will substantially interfere with the treatment, rehabilitation or other requirements outlined in this protocol.
  • Sustained severe burns (>10% total body surface area [TBSA] or >5% TBSA with full thickness or circumferential injury)
  • Compartment syndrome of the leg diagnosed preoperatively
  • Patients with pre-existing conditions, mental/psychosocial disorders, or who are taking medication that may delay or impair the fracture healing process or that could impact their ability to return for follow-up visits and/or complete the required assessments and postoperative rehabilitation. Examples include but are not limited to the following:
  • Renal insufficiency with serum creatinine of 3.5 mg/dL or higher or being treated with renal dialysis,
  • Uncontrolled diabetes mellitus with A1C of greater than or equal to 10%,
  • Serum Aspartate Aminotransferase (AST) greater than 2 times the upper limit of normal or diagnosed hepatitis C or hepatitis B,
  • Neurological or neuromuscular disorders affecting ambulatory capability or cognition, such as Parkinson's disease, myasthenia gravis, or stroke with relevant residual neurological deficit,
  • Current medications that could interfere with fracture healing such as systemic corticosteroids,
  • Morbid Obesity with BMI greater than or equal to 40 kg/m2,
  • A current endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, hyperthyroidism, parathyroid hormone disorder, Ehler-Danlos syndrome, osteogenesis imperfecta, or Cushing's disease),
  • History of osteomyelitis of index lower extremity or evidence of active soft tissue or bone infection at this site of injury at the time of DWC,
  • Patients with immune deficiency or history of auto-immune disease.
  • Patients with an active malignancy or a history of any invasive malignancy (except non-melanoma skin cancer), unless the patient has been treated with curative intent and there have been no clinical signs or symptoms of malignancy for at least 5 years.
  • Patients with any medical condition or life circumstances that in the surgeon's opinion could impact their ability to return for follow-up visits and/or complete the required assessments and postoperative rehabilitation. Examples include but are not limited to the following:
  • Patient lives too far away making the return for study visits to the surgeon's facility unlikely,
  • The patient has known alcohol or drug abuse within 3 months of screening to a degree that makes it unlikely the patient will follow study requirements.
  • Patients who are known to have anaphylactic or severe systemic reaction to human blood products, genipin, β-TCP, glycerin or to other components of the investigative product formulation.
  • Female patients of child-bearing potential who meet any of the following criteria:
  • Patient is currently pregnant (prior diagnosis or a positive pregnancy test at baseline), or planning to become pregnant any time during the course of the study
  • Currently breastfeeding or planning to breastfeed at any time during the course of the study
  • Upon stabilization of the tibia fracture, the patient has a bone gap greater than 1.0cm apparent by calibrated radiographs or by visual inspection and/or the patient is highly likely to require secondary intervention procedure(s), surgical or nonsurgical (e.g., bone stimulation or ultrasound treatment) for the index fracture.
  • Patients who have mal-alignment post-IM nailing of >10° in the coronal plane or >15° in the sagittal plane.
  • Patients who received only plates and screws for tibia fracture stabilization.
  • At the time of the DWC surgery, patients who have a planned secondary intervention procedure, surgical or nonsurgical (e.g., bone stimulation or ultrasound treatment) for the index fracture.
  • Patients being treated with any form of local antibiotics at the time of DWC.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Carmell Therapeutics

    Pittsburgh, Pennsylvania, 15203

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Controlled, Blinded Study of the Efficacy and Safety of Bone Healing Accelerant Versus Standard of Care in Subjects With Open Tibia Fractures

This clinical study is being conducted to demonstrate the safety and effectiveness of the Bone Healing Accelerant (BHA) product when applied to tibia (leg bone) fractures with an external wound or skin break (also called open tibia fractures). It is hypothesized that by 6 months, the number of subjects with successful bone healing will be greater in the BHA-treated group compared to subjects treated with standard of care alone. Open tibia fractures were chosen for this study because healing rates are typically longer than for other bone fractures due to the limited vascular supply, limited soft tissue coverage, and higher risk of infection.

Being tested
BHA
Medical subject headings
Tibial Fractures

What participants receive

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

  • BHACombination product

    BHA active ingredients include a blood-derived component and beta-tricalcium phosphate. It is applied directly to the bone fracture and nearby viable bone at the time of wound closure.

Study groups in NCT03826784
Study groupRoleWhat they receive
BHAExperimentalSubjects treated with BHA + standard of care
Receives: Combination Product: BHA
ControlNo interventionSubjects treated as per standard of care

What is being measured

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

  1. Composite healing measure

    Proportion of subjects in each arm meeting the healing success criteria. A binary (Yes/No) outcome for overall healing will be derived from the following three outcomes: Radiographic healing as measured by a score of at least 13 on the modified Radiographic Union Scale in Tibia fractures (mRUST, range bad to good 1-16), ambulation as measured by a score of at least 2 on the Function IndeX for Trauma scale (range bad to good 0-3), and no secondary intervention to promote bone healing. All three components must be met for a "yes" on composite healing.

    Measured: 6 months

Secondary outcomes (3)

  1. Radiographic healing

    Population mean Modified Radiographic Union Scale in Tibia Fractures (mRUST) scores (range bad to good is 4-16)

    Measured: 6 months

  2. Secondary intervention (surgical or nonsurgical)

    Proportion of subjects not having secondary intervention conducted specifically to promote bone healing needed

    Measured: 6 months

  3. Surgical site infection

    Proportion of subjects having surgical site infection through 12 months as determined by CDC guidelines

    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 posted1 Feb 2019
  2. Study startNov 2019 (estimated)
  3. Primary completionJan 2022 (estimated)
  4. Study completionFeb 2022 (estimated)

Why it stopped: Combined into an international study (CAR-BHA-I21)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03826784
Sponsor's protocol ID
CAR-BHA-U31
Status last verified
Jul 2019
First submitted
29 Jan 2019
Last updated
23 Jan 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BHA in people with Tibial Fractures, run by Carmell Therapeutics Corporation at 1 site 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 15 inclusion and 36 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: withdrawn, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite healing measure (time frame: 6 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 NCT03826784.

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 23 Jan 2020.

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