A Phase 1/2 interventional study of ALLOB® implantation in Long Bone Delayed-Union Fracture, sponsored by Bone Therapeutics S.A. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-11-10.
Sponsored by Bone Therapeutics S.A · Phase 1/2, Interventional, and Treatment
Fracture healing is a complex physiological process caused by interaction of cellular elements, cytokines and signaling proteins, which results in the formation of new bone. There is for now no universally accepted approach to evaluate the progression of fracture healing. Typically, a fracture is considered as a delayed-union when the bone has not united within a period of time that would be considered adequate for bone healing. Delayed-union suggests that union is slow but will eventually occur without additional surgical or non-surgical intervention, whereas non-union is defined as the cessation of all reparative process of healing.
The incidence of impaired healing is estimated to range from 5 to 10% of all long bone fractures, depending on the fracture site, the type and degree of injury, among other factors. Currently the treatment of choice remains bone allograft or autograft. This procedure shows in general good results but requires an invasive surgery of several hours under general anesthesia, followed by a few days of hospitalization. Because of this, major complications have been reported in up to 20-30% of patients.
The present Phase 1/2a study aims at demonstrating the safety and efficacy of ALLOB®, a proprietary population of allogeneic osteoblastic cells, in the treatment of delayed-union fractures of long bones. In this study, delayed-union is defined at the time of screening as an absence of healing of minimum 3 months and maximum 7 months (+/- 2 weeks) after the onset of the fracture.
723 studies on the registry are indexed under Fractures, Bone; 114 are open to participants now.
This study's enrollment of 25 is below the median of 80 across 458 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Bone Therapeutics S.A is the lead sponsor of 10 studies on the registry; none are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
One arm: ALLOB® Implantation
Drug: ALLOB® implantation
Each patient will undergo a single administration of ALLOB® into the delayed-union site under anesthesia.
Percentage of Responders at 6 Months (Efficacy of ALLOB)
The success of the study will be based on the percentage of treated patients (ALLOB®) not failing under treatment. A patient will be considered as failed under treatment if, at Month 6: - He/she had a rescue surgery Or - The Global Disease Evaluation score (VAS) as perceived by the patient has not improved by at least 25% and the Tomographic Union Score (TUS) as assessed by CT scan has not increased by at least two points (versus baseline).
Time frame: 6 months
| Milestone | ALLOB® Implantation |
|---|---|
| Started | 22 |
| Completed | 22 |
| Not completed | 0 |
The success of the study will be based on the percentage of treated patients (ALLOB®) not failing under treatment. A patient will be considered as failed under treatment if, at Month 6: - He/she had a rescue surgery Or - The Global Disease Evaluation score (VAS) as perceived by the patient has not improved by at least 25% and the Tomographic Union Score (TUS) as assessed by CT scan has not increased by at least two points (versus baseline).
| percent of patients | ALLOB® Implantation |
|---|---|
| Percentage of Responders at 6 Months (Efficacy of ALLOB) | 100 (86.71 to 100) |
Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ALLOB® Implantation | 0/22 (0%) | 2/22 (9.1%) | 9/22 (40.9%) |
| Event | ALLOB® Implantation |
|---|---|
| implant site infectionInfections and infestations | 1/22 |
| angioedemaSkin and subcutaneous tissue disorders | 1/22 |
| UrticariaSkin and subcutaneous tissue disorders | 1/22 |
| Event | ALLOB® Implantation |
|---|---|
| Procedural painInjury, poisoning and procedural complications | 5/22 |
| FallInjury, poisoning and procedural complications | 2/22 |
| Vitamin D DeficiencyMetabolism and nutrition disorders | 2/22 |
Safety population (all patients treated)
| Age, Continuous(years) | ALLOB® Implantation |
|---|---|
| Mean | 47.3 ± 13.96 |
| Sex: Female, Male(Participants) | ALLOB® Implantation |
|---|---|
| Female | 9 |
| Male | 13 |
| Race/Ethnicity, Customized(Participants) | ALLOB® Implantation |
|---|---|
| Caucasian/White | 22 |
| Region of Enrollment(participants) | ALLOB® Implantation |
|---|---|
| Belgium | 13 |
| Germany | 9 |
| BMI(kg/m^2) | ALLOB® Implantation |
|---|---|
| Mean | 26.73 ± 4.676 |
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
The record gives a start of Feb 2014, a primary completion of Sep 2017 and a completion of Jan 2020. It does not say whether these dates are actual or estimated.
Results were first posted in Sep 2021, 4 years after primary completion.
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This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Bone Therapeutics S.A