Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT01525667
Eligibility Criteria:
Inclusion Criteria:
1. Male or female subjects between 50 to 75 years of age
2. Scheduled THA
3. ASA Score ≤ 3
4. Signed written informed consent
Exclusion Criteria:
1. Muscle diseases
2. Severe neurological diseases
3. Opioid long term medication
4. Pain chronification \> stadium II of Gerbershagen
5. Immunosuppression due to illness or medication
6. Ankylosing spondylitis
7. History of ectopic bone formation of any localisation
8. Exclusion criteria for MRI (pace maker, defibrillator, ferromagnetic intracerebral clips)
9. Uncontrolled hypertension (defined as diastolic blood pressure \> 100 mmHg or systolic blood pressure \> 200 mmHg during screening)
10. Life-threatening ventricular arrhythmia or unstable angina - characterized by increasingly frequent episodes with modest exertion or at rest, worsening severity, and prolonged
11. ST segment elevation myocardial infarction and/or TIA/CVA within three (3) months prior to enrollment. Subjects with severe congestive heart failure symptoms (i.e. NYHA Stage IV)
12. Subject has malignancy undergoing treatment including chemotherapy, radiotherapy or immunotherapy
13. Body Mass Index (BMI) of 35 Kg/m2 or greater
14. Known allergies to protein products (horse or bovine serum, or porcine trypsin) used in the cell production process
15. Known HIV, syphilis at time of screening
16. Known active Hepatitis B, or Hepatitis C infection at the time of screening
17. Pregnant or breast-feeding women or women of childbearing potential not protected by an effective contraceptive method of birth control (defined as pearl index \< 1)
18. In the opinion of the investigator, the subject is unsuitable for cellular therapy
19. Subject is currently enrolled in, or has not yet completed a period of at least 30 days since ending other investigational device or drug trial(s)
20. Subjects who are legally detained in an official institute
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
75 Years
Study:
NCT01525667
Study Brief:
Protocol Section:
NCT01525667