E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Closed or open Gustilo I ans II humerus, tibial or femur diaphyseal or metaphysodiaphyseal fracture. |
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E.1.1.1 | Medical condition in easily understood language |
Patients with delayed consolidation after long bone fracture requiring graft apposition or alternative orthobiologics. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10017081 |
E.1.2 | Term | Fracture delayed union |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the safety of apposition of biomaterial with autologous MSCs at the fracture site |
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E.2.2 | Secondary objectives of the trial |
To obtain consolidation, without increasing the complication rate, of diaphyseal and/or metaphysodiaphyseal fractures (femur, tibia, humerus)status delayed union (after 3 months), treated by standard care procedures plus apposition of biomaterial with autologous MSCs at the fracture site. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- age 18 to 65 both sexes - traumatic isolated closed or open Gustilo I and II humerus, tibial or femur diaphyseal or metaphysodiaphyseal fracture status delayed union or non union - at least 3 months from acute fracture - able to provide informed consent, and signed informed consent - patients (by themselves) should have medical health care coverage to be included in a research study - able to understand and accept the study constraints |
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E.4 | Principal exclusion criteria |
- pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control - participation in another therapeutic trial previous 3 months - delayed union or non-union related to iatrogeny - segmental bone loss requiring therapy - vascular or neural injury - impossibility to meet appointments for the follow up - other fractures causing interference with weight bearing - infection viceral injuries of diseases interfering with callus formation - history of bone harvesting on iliac crest contraindicating bone-marriw aspiration - corticoid or immunosuppressive therapy more than one week in the 3 mionths prior ti study inclusion - history of prior concurrent diagnosis of HIV, Hepatitis B or C infection - insulin dependent diabetes - obesity - autoimmune inflammatory disease - current treatment by bisphonate or stopped in the 3 months prior to stydy inclusion - subject legally protected, under legal guardianship, deprived of their liberty by judicial or administrative decision, subject of psychiatric care, or admission a health facility. |
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E.5 End points |
E.5.1 | Primary end point(s) |
- local complication rate regarding the non-union treatment in the FU - local and general complication rate regarding potential effects of introducing the biomaterial with with MSC in the FU of patients. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
complication rates at weeks : 6, 12, 24 |
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E.5.2 | Secondary end point(s) |
- number of patients with proven bone healing, in proportion of the recruited , treated patients. - clinical consolidation - no reoperation done or scheduled - changes in serum levels of bone turnover markers
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- number of patients with proven bone healing at 6 weeks, 12 weeks, and 247 weeks - clinical consolidation at weeks 6, 12 24 - no reoperation done or scheduled at 24 weeks
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |