Application of bone marrow stem cells in order to induce union of vertebrae following spinal surgery - safety and efficacy study.

Phase 1

• Conditions: Spinal degenerative disease; MedDRA version: 17.0Level: LLTClassification code 10070241Term: Degenerative disc diseaseSystem Organ Class: 100000004859; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2010-024665-52-CZ
• Lead Sponsor: Bioinova, s.r.o.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-20
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

To participate in this trial, patients will have to meet following criteria:

1. established diagnosis of spinal degenerative disease indicated for lumbar spine surgery,

2. patients indicated for fusion therapy,

3. patients between 18–55 years, both sexes,

4. patients able to provide written informed consent.

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 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients meeting any of the following criteria shall not be allowed to participate in this study:

1. previous lumbar spine surgery,
2. osteoporosis,
3. diabetes mellitus,
4. pregnancy or breastfeeding,
5. women of childbearing potential not using effective contraception (established oral contraception, intrauterine device, ligation of the uterine tube) including proven contraceptive measures taken by their sexual partners,
6. fertile men not using proven contraceptive measures including effective contraception method (established oral contraception, intrauterine device, ligation of the uterine tube) in their partner,
7. coagulopathy,
8. malnutrition, primary biliar cirrhosis
9. skin infection at the site of bone marrow aspiration or at the site of spinal fusion,
10. gastrostomy,
11. 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, reccurent thromboembolic disease .....),
12. alcohol or drug abuse,
13. cancer (compulsory clinical oncological screening),
14. 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: Safety: To assess an absence of complications at the site of spinal fusion.<br>Efficacy: To assess the quality of spinal fusion measured according to Oswestry Questionnaire, dynamic X-rays and CT scan.<br>;Secondary Objective: Safety: Incidence of other treatment-emergent adverse events.<br>Overall safety.;Primary end point(s): Safety: To assess an absence of complications at the site of spinal fusion.;Timepoint(s) of evaluation of this end point: 12 months after the surgery and AMSC application.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To assess the quality of life measured by Oswestry Questionnaire and the quality of fusion measured by dynamic X-rays and CT scan .;Timepoint(s) of evaluation of this end point: 3 months and 12 months after the surgery and AMSC application.