Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01525667
Other study ID # PLX-PAD 1301-01
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received January 31, 2012
Last updated September 7, 2015
Start date November 2012
Est. completion date June 2015

Study information

Verified date January 2015
Source Pluristem Ltd.
Contact n/a
Is FDA regulated No
Health authority Germany: Paul-Ehrlich-Institut
Study type Interventional

Clinical Trial Summary

Local administration of PLX-PAD single dose, intra-muscular injection for the regeneration of injured gluteal musculature after Total Hip Arthroplasty (THA).


Description:

One of the main problems when performing THA via the standard transgluteal approach is the necessary injury of the gluteus medius muscle. The consecutive decrease of contractile muscle substance and the substitution by scar tissue leads to functional deficits of the pelvic-stabilizing musculature with an insufficiency limp in a large number of patients. In the long run the lack of musculature leads to a decrease in bone substance at the insertion sites of the gluteal muscles of the proximal femur. The present study has the aim of establishing a new therapy for iatrogenic gluteal muscle damage. The hypothesis of the present proposal is that intra-muscular (IM) injection of PLX-PAD into the iatrogenically injured gluteus medius muscle after THA results in an improved regeneration of the skeletal muscle tissue and consecutively in an improved functional outcome.

Subjects will be assigned to receive one of the two targeted doses of PLX-PAD or placebo. On the treatment day, after suturing the gluteus medius muscle PLX-PAD or placebo will be applied directly to the site of laceration.

Patients will be followed up for efficacy assessment up to week 26 and for safety assessment (Adverse events, vital signs, ECG, routinf lab and immunological testing) up to week 52 after THA. Patients will be phoned at week 104 in order to inquire about the occurence of new cancer.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date June 2015
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 50 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
150M PLX-PAD
Single course, multiple IM injections
300M PLX-PAD
Single course, multiple IM injections
Placebo
Single course, multiple IM injections

Locations

Country Name City State
Germany Charité Universitätsmedizin Berlin Berlin

Sponsors (1)

Lead Sponsor Collaborator
Pluristem Ltd.

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Day 0 to Week 26 in the Maximal Voluntary Isometric Contraction (MVIC) Moment of the Injured Side to Assess Gluteus Medius Strength. Change from Visit 2 (Day 0) to Week 26 in the maximal voluntary isometric contraction (MVIC) moment of the injured side as measured by isometric dynamometry to assess Gluteus Medius force strength. Day 0 to Week 26 No
Secondary Change From Day 0 to Week 26 in Muscle Volume. Change from Visit 2 (Day 0) to Week 26 in Muscle Volume as Measured by MRI. Day 0 to Week 26 No
Secondary Change From Day 1 to Week 12 in Mean Fiber Diameter. Change from Visit 3 (Day 1) to Week 12 in Mean Fiber Diameter as Measured by Muscle Biopsy. Day 1 to Week 12 No
Secondary Change From Day 0 to Week 26 in the Ratio of Injured to Contralateral Pelvic Shift . Change from Visit 2 (Day 0) to Week 26 in the Ratio of Injured to Contralateral Pelvic Shift as Measured by Gait Analysis Day 0 to Week 26 No
Secondary Change From Day 0 to Week 26 in the Visual Analog Scale (VAS) Pain Score. Visual Analog Scale (VAS) Pain Score ranges from 0 mm (no pain) to 100 mm (worse possible pain) Day 0 to Week 26 No
See also
  Status Clinical Trial Phase
Terminated NCT02818894 - Spinal Anesthesia in Total Hip Arthroplasty Phase 4
Completed NCT02242201 - Total Hip Arthroplasty (THA) Lumbar Plexus Verses Periarticular Phase 4
Completed NCT02414542 - Minima Clinical Study
Completed NCT01817010 - Strength and Function Following Total Hip Arthroplasty N/A
Completed NCT01443975 - Clinical Evaluation on the Use of the X-pander Device N/A
Recruiting NCT05530551 - Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With OA N/A
Recruiting NCT05530174 - Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With a Fracture N/A
Recruiting NCT06141928 - Comparison of Three Different Surgical Approaches on the Functional Outcome After Total Hip Arthroplasty N/A
Recruiting NCT05054192 - Reliability and Validity of Modified Four Square Step Test
Recruiting NCT04492462 - The Impact of Two Different Physical Therapy Programs in the Rehabilitation of Patients Undergoing Anterior Approach Hip Replacement Surgery N/A
Withdrawn NCT02926651 - Single Versus Multi-Dose Oral Tranexamic Acid in Patients at High Risk for Blood Transfusion After Total Joint Arthroplasty Phase 4
Completed NCT02308813 - Predictability of the Ability to Perform an Emergency Stop With Disorders of the Hip N/A
Recruiting NCT02032017 - Percutaneous Assisted Approach for Total Hip Replacement and it's Effect on Functional Rehabilitation. N/A
Recruiting NCT01312077 - The Analgesic Efficacy of Periarticular Infiltration of Local Anaesthetic for Total Hip Replacement Phase 4
Withdrawn NCT01380665 - Prevena™ Incision Management System Over Primarily Closed Hip and Knee Incisions in Patients Immediately Post Total Hip and Knee Arthroplasty Phase 4
Recruiting NCT05893563 - Corail Stability at 5-Years Post-Total Hip Arthroplasty
Recruiting NCT06088069 - Effect of Virtual Reality on Perioperative Anxiety, Stress and Pain in Total Hip Arthroplasty N/A
Active, not recruiting NCT03210844 - The Clinical Outcomes After Direct Anterior Approach and Microposterior Approach for Total Hip Arthroplasty N/A
Recruiting NCT04801680 - Mpact 3D Metal Cup PMS
Terminated NCT02006251 - Real-Time Instrument for Acetabular Shell Positioning