Revision total hip arthroplasty MedDRA version: 20.0 Level: LLT Classification code 10044088 Term: Total hip replacement System Organ Class: 100000004865
Conditions
Interventions
Product Name: Suspension of human autologous MSC 3P in 1.5ml
Product Code: AMSC
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Human Autologous Mesenchymal Stem Cells
Current Spons
Sponsors
Fakultní nemocnice Hradec Králové
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To participate in this trial, patients have to meet following criteria: 1. Established diagnosis of aseptic loosening of a total hip arthoplasty indicated for revision hip surgery; 2. Subjects with extensive femoral bone defects; 3. Age between 18-75 years, both sexes, and - for subjects aged 18 to 65 years: ASA score I to III - for subjects aged 66 to 75 years: ASA score I to II 4. Able to provide written informed consent (ASA score: A physical status classification systém of the American Society of Anesthesiologist for assessing the fitnes of patients befor surgery) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 4 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria shall not be allowed to principate in thos study: 1. Previous infection at the site of total hip arthroplasty 2. Rheumatoid arthritis 3. Pregnancy or breastfeeding 4. Women of childbearing potential not using effective contraception (established oral contraception, intrauterine device, ligation of the uterine tube) including proven contaceptive measures taken by their sexual partners 5. fertile men not using proven contraceptive measures including effective contraception method (established oral contraception, intrauterine device, ligation of the uterine tube) in their partner 6. skin infection at the site of bone marrow aspiration or at the site of total hip arthroplasty 7. malnutrition, primary biliar cirrhosis 8. any significant medical condition that would compromise the safety of the patient (e.g. recent myocardial infarction, congestive heart failure, renal failure, liver failure, systemic infection, ...) 9. alcohol or drug abuse 10. cancer (compulsory clinical oncological screening) 11. osteonecrosis of pelvis and hip due to past radiation treatment 12. ongoing and recent (last 3 months) systemic corticosteroid or immunosuppressive therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The goal of this study is to assess the safety and the efficacy of beta-tricalcium phosphate biomaterial containing autologous mesenchymal stem cells. PrimaryObjective - Safety: To document absence of complication at the site of femoral bone defect. To assess overal profile of untoward events in study subjects.;Secondary Objective: Safety: Incidence of other study treatment-emergent adverse events. Overal safety. Efficacy: To assess the quality of healing of femoral bone defects as evaluated by Harris Hip Score, plain X-rays and densitometry, in comparison to referral data.;Primary end point(s): Primary endpoint: Safety: To assess an absence of complications at the site of revision total hip arthroplasty.;Timepoint(s) of evaluation of this end point: At each visit since Visit V (1 days post-surgery) until Visit X (12 months postsurgery). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To assess the quality of life measured by Harris Hip Score and the quality of healing measured by plain X-rays and densitometry 12 month after surgery.;Timepoint(s) of evaluation of this end point: At Visit X (12 months postsurgery) | — |
Countries
Czech Republic
Contacts
Public ContactPeter Bažant, Director
Bioinova, s.r.o.
Outcome results
None listed