Recalcitrant Lower Limb NonunionPhase 1/2NCT06335394
Prospective Study in Adults Evaluating Safety & Efficacy of NVD003 for Bone Reconstruction to Treat Lower Limb Nonunion
A Phase 1/2 study testing NVD003 in people with Recalcitrant Lower Limb Nonunion, run by Novadip Biosciences at 10 sites in 3 countries.
Trial summary
The goal of this clinical trial is to evaluate the safety and preliminary efficacy of the autologous 3D osteogenic implant NVD-003 for bone reconstruction for the treatment of recalcitrant lower limb nonunion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recalcitrant Lower Limb Nonunion
- What is being tested?
- NVD003
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 2 Aug 2018to 15 May 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female adult subject (≥18 years).
- Radiographic images not older than 3 months, confirming lower limb nonunion, defined as the absence of clinical and radiographic progression towards healing over 3 consecutive months on serial radiographs and minimum 9 months after the first attempt of surgical bone repair, or minimum 6 months after the second (or any subsequent) attempt of surgical bone repair.
- Radiologic single, meta- and/or diaphyseal bone defect with a maximum size of 4 cm (in case of a void that does not transverse the whole width of the bone, the total volume cannot exceed the volume corresponding to the 4 cm gap).
- The impaired limb is salvageable, and the patient is eligible for the intended surgical procedure according to the standard hospital practice.
- Documented normal or low bone density: Bone density scan determined by Dual Energy X-Ray Absorptiometry DEXA scan on lumbar spine and hip (bone mineral density T-scores above -2.5). An examination ≤ 1-year-old before screening is acceptable.
- The subject is, in the Investigator's opinion, psychosocially, mentally, and physically able to fully comply with this protocol, including the postoperative regimen and follow-up visits.
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- Use of an effective birth control method for 2 months prior to the date of the intended surgical intervention up to Visit V7 for women of childbearing potential.
- Negative urinary pregnancy test for women of childbearing potential.
- At screening, safety local laboratory test results are medically acceptable to undergo surgery (see Section 7.3.2) and serology results are in accordance with country specific requirements for donation of Human Body Material.
- At time of adipose tissue collection, central laboratory serology and molecular tests panel for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and syphilis are in accordance with Belgian specific requirements for release of Human Body Material.
- The subject has understood the nature of the study, agrees to its provisions, and has accepted to participate in the study and to follow all study procedures. This is acknowledged by signing the informed consent as approved by the required Institutional Review Board/Ethics Committee and the national competent authorities.
- Patient fulfils the criteria to donate his human body material (adipose tissue) and is suitable to undergo a liposuction.
Who cannot join
- The subject has a Body Mass Index (BMI) ≤ 20 kg/m² or ≥ 40 kg/m², or of ≥35 kg/m² with obesity-related health conditions, such as high blood pressure or diabetes.
- Multifocal or comminuted fractures.
- A planned use of an external fixator is not allowed as of the grafting surgery (V1) until V7.
- Documented osteoporosis: bone density determined using DEXA scan on lumbar spine and hip: bone mineral density T-scores of -2.5 and below. An examination ≤ 1-year-old before screening is acceptable.
- Pregnant or breast-feeding woman.
- The subject shows signs of an active drug or alcohol dependence, serious current illness, mental illness or any other factors which, in the opinion of the investigator, will interfere with study conduct or the interpretation of the results.
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- The patient has a history of solid organ transplant at any point in the past or is on the waiting list for future organ transplantation.
- The subject previously received a cellular therapy treatment at any point in time (as per protocol description).
- Previous exposure to any experimental therapy with another investigational drug within 60 days prior to screening or enrolment in any concurrent study that may confound the results of this study.
- Any signs or suspicion of an active local (area of the future surgical site), or systemic infection before the induced membrane surgery or the grafting surgery.
- Known allergy to any antibiotics commonly used to treat Staphylococcus aureus (including methicillin-resistant Staphylococcus aureus) or coagulase-negative staphylococci.
- Diagnosis of HIV, HBV (HBsAg or PCR positive), HCV, Human T-cell Lymphotropic Virus (HTLV) 1 or 2, or syphilis infection (as confirmed by serology and nucleic acid test (NAT) by Tissue Establishment).
- Chronic use of immunosuppressive therapy (immunosuppressant/ immunotherapy) due to inflammatory or systemic disease.
- Any clinically relevant chronic disease associated with renal or hepatic insufficiency or any chronic disease of such severity that surgery could be detrimental to the survival of the patient.
- Subjects with poorly controlled diabetes mellitus type 2 as assessed by glycated haemoglobin (HbA1C) ≥ 10%.
- Subjects with poorly controlled thyroid diseases (unstable despite proper medication).
- Subjects with documented metabolic bone disease (based on the investigator judgment) such as, but not limited to, osteogenesis imperfecta or osteomalacia.
- Chronic, current or planned during study use of any medications that might affect bone metabolism or the quality of bone formation such as, but not limited to, bisphosphonates, steroids, methotrexate, anticoagulant therapies, immunosuppressant therapy or immunotherapy. However, short lasting surgery-related prophylactic treatments such as antibiotics, analgesics and low molecular heparin drugs may be administered according to hospital recommendations.
- Existing malignant tumour in the vicinity of the graft or a resected one not cured for more than 5 years.
- Any other illness which might reduce life expectancy to less than 2 years from screening.
- The subject is a prisoner.
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Belgium8 sites
Centre Hospitalier Interregional Edith Cavel (CHIREC) - Clinique Ste Anne-St Remi
Anderlecht, 1070
Algemeen Ziekenhuis (AZ) Sint-Jan Brugge - Oostende AV - Campus Sint-Jan
Bruges, 8000
Centre Hospitalier Universitaire CHU/UVC Brugmann (Site Horta)
Brussels, 1020
Grand Hôpital De Charleroi
Charleroi
Ziekenhuis Oost-Limburg (ZOL)
Genk, 3600
Universitair Ziekenhuis Leuven, Campus Gasthuisberg
Leuven, 3000
CHU Ambroise Paré
Mons, 7000
Centre Hospitalier Regional De Namur
Namur, 5000
About this study
Official title: A Prospective Multicentre Single-arm Study in Adults to Evaluate the Safety and Preliminary Efficacy of the Autologous 3D Osteogenic Implant NVD-003 for Bone Reconstruction for the Treatment of Recalcitrant Lower Limb Nonunion
The goal of this clinical trial is to evaluate the safety and preliminary efficacy of the autologous 3D osteogenic implant NVD-003 for bone reconstruction for the treatment of recalcitrant lower limb nonunion.
Read the detailed description
This is a first in man study conducted as a prospective, single-arm, non-randomized clinical study. A sample of 5 to 10 patients will be enrolled in the study in order to assess the safety of the use of NVD-003 bone graft implantation in patients with recalcitrant lower limb nonunion.
The sample size of 5 to 10 patients was considered sufficient to give a preliminary indication on the safety of the ATMP.
- Conditions
- Recalcitrant Lower Limb Nonunion
- Being tested
- NVD003
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NVD003Other
Autologous osteogenic implant NVD-003 for bone reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Single-arm study | Experimental | NVD003 Receives: Other: NVD003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Adverse Events
All Adverse Events (AEs) including Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and Procedure Related AE's (PRAE).
Measured: From graft implantation until completion of visit 24 months
Safety - Abnormalities of vital signs
Vital signs abnormalities: blood pressure
Measured: At hospital discharge (1-2 weeks after grafting surgery), at visit 1,5 months, at visit 3 months, at visit 6 months, at visit 12 months and visit 24 months
Safety - Abnormalities of vital signs
Vital signs abnormalities: heart rate
Measured: At hospital discharge (1-2 weeks after grafting surgery), at visit 1,5 months, at visit 3 months, at visit 6 months, at visit 12 months and visit 24 months
Safety - Abnormalities of physical examination
Physical examinations abnormalities: cardiovascular system
Measured: At hospital discharge (1-2 weeks after grafting surgery), at visit 1,5 months, at visit 3 months, at visit 6 months, at visit 12 months and visit 24 months
Safety - Abnormalities of physical examination
Physical examinations abnormalities: respiratory system
Measured: At hospital discharge (1-2 weeks after grafting surgery), at visit 1,5 months, at visit 3 months, at visit 6 months, at visit 12 months and visit 24 months
Safety - Abnormalities of physical examination
Physical examinations abnormalities: legs examination (inspection of both legs and extensive examination of the affected leg)
Measured: At hospital discharge (1-2 weeks after grafting surgery), at visit 1,5 months, at visit 3 months, at visit 6 months, at visit 12 months and visit 24 months
Safety - Abnormalities of laboratories
Safety laboratories abnormalities: blood sampling: haematology (tests that yield information on the qualitative and quantitative composition of the cellular components of the blood)
Measured: At hospital discharge (1-2 weeks after grafting surgery), at visit 1,5 months, at visit 3 months, at visit 6 months, at visit 12 months and visit 24 months
Safety - Abnormalities of laboratories
Safety laboratories abnormalities: blood sampling: coagulation (measure your blood's ability to clot, and how long it takes to clot)
Measured: At hospital discharge (1-2 weeks after grafting surgery), at visit 1,5 months, at visit 3 months, at visit 6 months, at visit 12 months and visit 24 months
Safety - Abnormalities of laboratories
Safety laboratories abnormalities: blood sampling: biochemistry (tests to evaluate organ function, electrolyte status, hormone levels and more (calcium, vitamin D))
Measured: At hospital discharge (1-2 weeks after grafting surgery), at visit 1,5 months, at visit 3 months, at visit 6 months, at visit 12 months and visit 24 months
Secondary outcomes (13)
Healing efficacy: plain X-ray
Plain X-ray healing defined as 3 united cortices (the strong type of bone on the outer layer) out of 4, on antero-posterior and lateral X-ray views
Measured: At 6 weeks, 3 months, 6 months, 12 months, at additional visits (if no healing at 12 months after graft implant surgery) up to 24 months.
Healing efficacy: CT-scan
Computerized Tomography (CT)-scan healing defined as 3 united cortices out of 4
Measured: At 6, 12 and 24 months
Healing efficacy: average time from Investigational Medicinal Product grafting surgery till first observation of plain X-ray and CT-scan confirmed fracture healing
The average time from IMP grafting surgery till first observation of plain X-ray and CT-scan confirmed fracture healing
Measured: Average time from IMP grafting surgery till first observation of plain X-ray and CT-scan up to 24 months
Healing efficacy: investigator assessed clinical healing
Investigator assessed clinical healing based on the overall clinical evaluation of the patient: ability to bear weight (non-weight bearing, toe-touch weight bearing, partial weight bearing, full weight bearing and full weight bearing with walking), the pain score at palpation at the fracture site (patient to rate the pain from 0 to 10 with the understanding that 0 is equal to no pain and 10 is equal to worst possible pain) and the pain medication intake by the patient.
Measured: From 6 weeks post-grafting onwards up to 24 months
Healing efficacy: average time from IMP grafting surgery to Investigator assessed clinical healing
The average time from IMP grafting surgery to Investigator assessed clinical healing
Measured: Time from grafting surgery till first observation of investigator assessed clinical healing up to 24 months
Grafting Surgery parameters
Parameter 1: duration of grafting surgery
Measured: Duration of grafting surgery (visit 1) and duration of hospitalization after grafting surgery (visit 2)
Grafting Surgery parameters
Parameter 2: duration of hospitalization
Measured: Duration of grafting surgery (visit 1) and duration of hospitalization after grafting surgery (visit 2)
Complications: rate of subsequent surgical interventions
Rate of subsequent surgical interventions (e.g. revision, removal, reoperation and/or supplemental fixation)
Measured: At 12 and 24 months post-implant surgery
Quality of Life: pain evaluation
Pain evaluation with the Brief Pain Inventory (Short Form) (BPI-SF) (pain severity and pain interference with function)
Measured: At screening and at 6 weeks, 3, 6, 12 and 24 months post-graft
Quality of Life: questionnaire EuroQol-5 Dimensions
QoL questionnaire EuroQol-5 Dimensions (EQ-5D-5L)
Measured: At screening and at 6 weeks, 3, 6, 12 and 24 months post-graft
Quality of Life: overall treatment effect
Overall Treatment Effect rating scale
Measured: At 3, 6, 12 and 24 months post-graft
General Pre-graft implantation safety: all SAEs, AESI and PRAE
All AEs including Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and Procedure Related AE's (PRAE).
Measured: Pre-graft implantation
All SAEs during the extended safety follow-up period
All Serious Adverse Events (SAEs).
Measured: During the extended safety follow-up period (between 24 months FU visit and 5 years post-grafting surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start2 Aug 2018
- Primary completion27 Apr 2022
- Study completion15 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recalcitrant Lower Limb NonunionStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novadip Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christophe Marchal, MD, Principal investigator, CHU Ambroise Paré
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335394
- Sponsor's protocol ID
- NVD003-CLN01
- Status last verified
- Mar 2024
- First submitted
- 21 Nov 2023
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicentre Single-arm Study in Adults to Evaluate the Safety and Preliminary Efficacy of the Autologous 3D Osteogenic Implant NVD-003 for Bone Reconstruction for the Treatment of Recalcitrant Lower Limb Nonunion
- ClinicalTrials.gov ID
- NCT06335394
- Acronym / sponsor ID
- NVD003-CLN01
- Conditions
- Recalcitrant Lower Limb Nonunion
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Novadip BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2018 (actual)
- Primary completion
- 27 Apr 2022 (actual)
- Study completion
- 15 May 2028 (estimated)
- First posted
- 28 Mar 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.
The goal of this clinical trial is to evaluate the safety and preliminary efficacy of the autologous 3D osteogenic implant NVD-003 for bone reconstruction for the treatment of recalcitrant lower limb nonunion.
Detailed description
This is a first in man study conducted as a prospective, single-arm, non-randomized clinical study. A sample of 5 to 10 patients will be enrolled in the study in order to assess the safety of the use of NVD-003 bone graft implantation in patients with recalcitrant lower limb nonunion.
The sample size of 5 to 10 patients was considered sufficient to give a preliminary indication on the safety of the ATMP.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm study | Experimental | Other: NVD003NVD003 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female adult subject (≥18 years).
- Radiographic images not older than 3 months, confirming lower limb nonunion, defined as the absence of clinical and radiographic progression towards healing over 3 consecutive months on serial radiographs and minimum 9 months after the first attempt of surgical bone repair, or minimum 6 months after the second (or any subsequent) attempt of surgical bone repair.
- Radiologic single, meta- and/or diaphyseal bone defect with a maximum size of 4 cm (in case of a void that does not transverse the whole width of the bone, the total volume cannot exceed the volume corresponding to the 4 cm gap).
- The impaired limb is salvageable, and the patient is eligible for the intended surgical procedure according to the standard hospital practice.
- Documented normal or low bone density: Bone density scan determined by Dual Energy X-Ray Absorptiometry DEXA scan on lumbar spine and hip (bone mineral density T-scores above -2.5). An examination ≤ 1-year-old before screening is acceptable.
Key exclusion criteria (21 listed)
- The subject has a Body Mass Index (BMI) ≤ 20 kg/m² or ≥ 40 kg/m², or of ≥35 kg/m² with obesity-related health conditions, such as high blood pressure or diabetes.
- Multifocal or comminuted fractures.
- A planned use of an external fixator is not allowed as of the grafting surgery (V1) until V7.
- Documented osteoporosis: bone density determined using DEXA scan on lumbar spine and hip: bone mineral density T-scores of -2.5 and below. An examination ≤ 1-year-old before screening is acceptable.
- Pregnant or breast-feeding woman.
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 |
|---|---|---|
| NVD003Autologous osteogenic implant NVD-003 for bone reconstruction | Other | Single-arm study |
Primary outcome
Safety - Adverse Events
Time frame: From graft implantation until completion of visit 24 months
All Adverse Events (AEs) including Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and Procedure Related AE's (PRAE).
Safety - Abnormalities of vital signs
Time frame: At hospital discharge (1-2 weeks after grafting surgery), at visit 1,5 months, at visit 3 months, at visit 6 months, at visit 12 months and visit 24 months
Vital signs abnormalities: blood pressure
Safety - Abnormalities of vital signs
Time frame: At hospital discharge (1-2 weeks after grafting surgery), at visit 1,5 months, at visit 3 months, at visit 6 months, at visit 12 months and visit 24 months
Vital signs abnormalities: heart rate
Safety - Abnormalities of physical examination
Time frame: At hospital discharge (1-2 weeks after grafting surgery), at visit 1,5 months, at visit 3 months, at visit 6 months, at visit 12 months and visit 24 months
Physical examinations abnormalities: cardiovascular system
Safety - Abnormalities of physical examination
Time frame: At hospital discharge (1-2 weeks after grafting surgery), at visit 1,5 months, at visit 3 months, at visit 6 months, at visit 12 months and visit 24 months
Physical examinations abnormalities: respiratory system
Safety - Abnormalities of physical examination
Time frame: At hospital discharge (1-2 weeks after grafting surgery), at visit 1,5 months, at visit 3 months, at visit 6 months, at visit 12 months and visit 24 months
Physical examinations abnormalities: legs examination (inspection of both legs and extensive examination of the affected leg)
Safety - Abnormalities of laboratories
Time frame: At hospital discharge (1-2 weeks after grafting surgery), at visit 1,5 months, at visit 3 months, at visit 6 months, at visit 12 months and visit 24 months
Safety laboratories abnormalities: blood sampling: haematology (tests that yield information on the qualitative and quantitative composition of the cellular components of the blood)
Safety - Abnormalities of laboratories
Time frame: At hospital discharge (1-2 weeks after grafting surgery), at visit 1,5 months, at visit 3 months, at visit 6 months, at visit 12 months and visit 24 months
Safety laboratories abnormalities: blood sampling: coagulation (measure your blood's ability to clot, and how long it takes to clot)
Safety - Abnormalities of laboratories
Time frame: At hospital discharge (1-2 weeks after grafting surgery), at visit 1,5 months, at visit 3 months, at visit 6 months, at visit 12 months and visit 24 months
Safety laboratories abnormalities: blood sampling: biochemistry (tests to evaluate organ function, electrolyte status, hormone levels and more (calcium, vitamin D))
13 secondary outcomes
Healing efficacy: plain X-ray
Time frame: At 6 weeks, 3 months, 6 months, 12 months, at additional visits (if no healing at 12 months after graft implant surgery) up to 24 months.
Healing efficacy: CT-scan
Time frame: At 6, 12 and 24 months
Healing efficacy: average time from Investigational Medicinal Product grafting surgery till first observation of plain X-ray and CT-scan confirmed fracture healing
Time frame: Average time from IMP grafting surgery till first observation of plain X-ray and CT-scan up to 24 months
Healing efficacy: investigator assessed clinical healing
Time frame: From 6 weeks post-grafting onwards up to 24 months
Healing efficacy: average time from IMP grafting surgery to Investigator assessed clinical healing
Time frame: Time from grafting surgery till first observation of investigator assessed clinical healing up to 24 months
Grafting Surgery parameters
Time frame: Duration of grafting surgery (visit 1) and duration of hospitalization after grafting surgery (visit 2)
Grafting Surgery parameters
Time frame: Duration of grafting surgery (visit 1) and duration of hospitalization after grafting surgery (visit 2)
Complications: rate of subsequent surgical interventions
Time frame: At 12 and 24 months post-implant surgery
Quality of Life: pain evaluation
Time frame: At screening and at 6 weeks, 3, 6, 12 and 24 months post-graft
Quality of Life: questionnaire EuroQol-5 Dimensions
Time frame: At screening and at 6 weeks, 3, 6, 12 and 24 months post-graft
Quality of Life: overall treatment effect
Time frame: At 3, 6, 12 and 24 months post-graft
General Pre-graft implantation safety: all SAEs, AESI and PRAE
Time frame: Pre-graft implantation
All SAEs during the extended safety follow-up period
Time frame: During the extended safety follow-up period (between 24 months FU visit and 5 years post-grafting surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
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.
Christophe Marchal, MD principal investigator
CHU Ambroise Paré
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NVD003 in people with Recalcitrant Lower Limb Nonunion, run by Novadip Biosciences at 10 sites in 3 countries.
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 21 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: under way, not looking for participants, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Belgium, Luxembourg, Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
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?
Safety - Adverse Events (time frame: From graft implantation until completion of visit 24 months). The study lists 9 primary outcomes in all. 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 28 Mar 2024; AzTrials last refreshed its copy on 7 Nov 2026.