Innovation of method cryopreservation for clinical use autologous multipotent mesenchymal stem cells (MSCs)
- Conditions
- MedDRA version: 20.0Level: LLTClassification code 10044088Term: Total hip replacementSystem Organ Class: 100000004865Revision total hip arthroplastyTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
- Registration Number
- EUCTR2016-000926-21-CZ
- Lead Sponsor
- Fakultní nemocnice Hradec Králové
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 6
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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:<br>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.<br>Overal safety.<br>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:<br>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 Outcome Measures
Name Time Method 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<br>surgery.;Timepoint(s) of evaluation of this end point: At Visit X (12 months postsurgery)