A Phase I/II, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Intramuscular Application of Cells from another Person for Regeneration of Injured Hip-Muscles after Hip Joint Replacement Surgery

• Conditions: Regeneration of injured Gluteal Musculature (GM) after Total Hip Arthroplasty (THA); MedDRA version: 14.1Level: LLTClassification code 10048793Term: CoxarthrosisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2011-003934-16-DE
• Lead Sponsor: Pluristem Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-14
• Last Update Posted: 29 October 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1. Adult male or female subjects between 50 to 75 years of age at the time of screening visit.
2. Scheduled THA
3. ASA Score = 3
4. Signed 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 6
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

1. Muscle diseases
2. Sever 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 ofectopic 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified