Foot DeformitiesPhase 2NCT06258499
Bone Healing Accelerant (BHA) Versus Autologous Bone Grafting (ABG) for Hindfoot or Ankle Arthrodesis
A Phase 2 study testing BHA in people with Foot Deformities, run by Carmell Therapeutics Corporation.
Trial summary
This study is being conducted to demonstrate the safety and effectiveness of Bone Healing Accelerant (BHA) product when applied to the joint space of the ankle of hindfoot (the section of the foot immediately below the ankle joint) during fusion surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Foot Deformities
- What is being tested?
- BHA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Nov 2024
- Phase
- Phase 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has pain with weight-bearing in the joint(s) below that, in the opinion of the Investigator, warrants arthrodesis:
- Tibiotalar (ankle)
- Talocalcaneal (subtalar)
- Talonavicular
- Calcaneocuboid
- Double hindfoot (e.g., talonavicular and talocalcaneal joints)
Show all 11Show fewer
- Triple hindfoot (subtalar, talonavicular and calcaneocuboid joints
- Joint space(s) can, in the opinion of the Investigator, be adequately filled with no more than 9 cc of graft material (BHA or ABG)
- Each fused joint can be adequately compressed and rigidly stabilized with plates, screws, staples or a combination thereof. External fixation, percutaneous Kirschner wires or intramedullary rods may not be used.
- Patient is willing and able to comply with all study requirements including all postoperative clinical and radiographic evaluations.
- If patient is a woman of childbearing bearing potential (not post-menopausal for 12 months or surgically sterile), patient has a urine pregnancy test with a negative result at screening and on the day of surgery, prior to the procedure. These trial participants must commit to adequate birth control through the 52-week follow-up
Who cannot join
- Skeletally immature patients (i.e., radiographic evidence of open physes), regardless of age
- Bone deficit, defect or void requiring a structural graft
- Condition requiring intramedullary nailing or external fixation for the arthrodesis
- Condition requiring osteotomy or fusion of any midfoot joints.
- Prior arthroplasty, arthrodesis, major surgical repair or reconstruction of the index ankle or hindfoot joints.
About this study
Official title: A Multicenter, Randomized, Controlled, Blinded Study of the Safety and Efficacy of Bone Healing Accelerant Versus Autologous Bone Grafting in Subjects Undergoing Hindfoot or Ankle Arthrodesis and Who Require Supplementary Grafting
This study is being conducted to demonstrate the safety and effectiveness of Bone Healing Accelerant (BHA) product when applied to the joint space of the ankle of hindfoot (the section of the foot immediately below the ankle joint) during fusion surgery. It is hypothesized that by 6 months, the number of subjects with successful bone fusion will be greater in the BHA-treated group compared to subjects treated with standard of care alone.
- Conditions
- Foot Deformities
- Being tested
- BHA
- Medical subject headings
- Foot Deformities
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 manually placed into the joint fusion space during fusion surgery.
| Study group | Role | What they receive |
|---|---|---|
| BHA | Experimental | Subjects treated with BHA + standard of care Receives: Combination Product: BHA |
| Control | No intervention | Subjects treated as per standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Radiographic Fusion
Greater than or equal to 50% bone bridging across joint space for the full complement of joints fused as determined by CT in the absence of secondary surgical or nonsurgical interventions intended to promote fusion.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study startMar 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionNov 2024 (estimated)
Why it stopped: study never started and is on hold until further notice
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot DeformitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmell Therapeutics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258499
- Sponsor's protocol ID
- CAR-BHA- U22
- Status last verified
- Feb 2024
- First submitted
- 6 Feb 2024
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled, Blinded Study of the Safety and Efficacy of Bone Healing Accelerant Versus Autologous Bone Grafting in Subjects Undergoing Hindfoot or Ankle Arthrodesis and Who Require Supplementary Grafting
- ClinicalTrials.gov ID
- NCT06258499
- Acronym / sponsor ID
- CAR-BHA- U22
- Conditions
- Foot Deformities
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study never started and is on hold until further notice
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Carmell Therapeutics CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to demonstrate the safety and effectiveness of Bone Healing Accelerant (BHA) product when applied to the joint space of the ankle of hindfoot (the section of the foot immediately below the ankle joint) during fusion surgery. It is hypothesized that by 6 months, the number of subjects with successful bone fusion will be greater in the BHA-treated group compared to subjects treated with standard of care alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BHA | Experimental | Combination Product: BHASubjects treated with BHA + standard of care |
| Control | No intervention | –Subjects treated as per standard of care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient has pain with weight-bearing in the joint(s) below that, in the opinion of the Investigator, warrants arthrodesis:
- Joint space(s) can, in the opinion of the Investigator, be adequately filled with no more than 9 cc of graft material (BHA or ABG)
- Each fused joint can be adequately compressed and rigidly stabilized with plates, screws, staples or a combination thereof. External fixation, percutaneous Kirschner wires or intramedullary rods may not be used.
- Patient is willing and able to comply with all study requirements including all postoperative clinical and radiographic evaluations.
- If patient is a woman of childbearing bearing potential (not post-menopausal for 12 months or surgically sterile), patient has a urine pregnancy test with a negative result at screening and on the day of surgery, prior to the procedure. These trial participants must commit to adequate birth control through the 52-week follow-up
Key exclusion criteria (5 listed)
- Skeletally immature patients (i.e., radiographic evidence of open physes), regardless of age
- Bone deficit, defect or void requiring a structural graft
- Condition requiring intramedullary nailing or external fixation for the arthrodesis
- Condition requiring osteotomy or fusion of any midfoot joints.
- Prior arthroplasty, arthrodesis, major surgical repair or reconstruction of the index ankle or hindfoot joints.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BHABHA active ingredients include a blood-derived component and beta-tricalcium phosphate. It is manually placed into the joint fusion space during fusion surgery. | Combination product | BHA |
Primary outcome
Successful Radiographic Fusion
Time frame: 24 weeks
Greater than or equal to 50% bone bridging across joint space for the full complement of joints fused as determined by CT in the absence of secondary surgical or nonsurgical interventions intended to promote fusion.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
Related trials for Foot Deformities
Not yet recruiting
Three Foot Orthosis Interventions for Progressive Collapsing Foot Deformity
Progressive Collapsing Foot Deformity
Not yet recruitingObservational study
Foot Care in Care Homes
Foot & Ankle, Foot Care
Recruiting
ENMS With Balance Feedback for Post-stroke Ankle-foot Rehabilitation
Cerebrovascular Stroke, Foot Drop
Not yet recruitingObservational study
Prevalence of Foot Deformities Among Adolescents in Egyptian Population
Foot Deformities
Not yet recruitingObservational study
Translation, Cross-cultural Adaptation, and Validation of the FPI-6 in Spain
Foot Deformities, Flatfoot
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BHA in people with Foot Deformities, run by Carmell Therapeutics Corporation.
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 11 inclusion and 5 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 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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 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?
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?
Successful Radiographic Fusion (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2024; AzTrials last refreshed its copy on 6 Nov 2026.