Total Hip ArthroplastyPhase 1/2NCT01525667
Safety and Efficacy of IM Injections of PLX-PAD for the Regeneration of Injured Gluteal Musculature After Total Hip Arthroplasty
A Phase 1/2 study testing 150M PLX-PAD and 300M PLX-PAD in people with Total Hip Arthroplasty and Muscle Injury, run by Pluristem Ltd. at 1 site in Germany.
Trial summary
Local administration of PLX-PAD single dose, intra-muscular injection for the regeneration of injured gluteal musculature after Total Hip Arthroplasty (THA). Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Total Hip Arthroplasty, Muscle Injury
- What is being tested?
- 150M PLX-PAD and 300M PLX-PAD
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2012to Jun 2015
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects between 50 to 75 years of age
- Scheduled THA
- ASA Score ≤ 3
- Signed written informed consent
Who cannot join
- Muscle diseases
- Severe neurological diseases
- Opioid long term medication
- Pain chronification > stadium II of Gerbershagen
- Immunosuppression due to illness or medication
- Ankylosing spondylitis
Show all 20Show fewer
- History of ectopic bone formation of any localisation
- Exclusion criteria for MRI (pace maker, defibrillator, ferromagnetic intracerebral clips)
- Uncontrolled hypertension (defined as diastolic blood pressure > 100 mmHg or systolic blood pressure > 200 mmHg during screening)
- Life-threatening ventricular arrhythmia or unstable angina - characterized by increasingly frequent episodes with modest exertion or at rest, worsening severity, and prolonged
- 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)
- Subject has malignancy undergoing treatment including chemotherapy, radiotherapy or immunotherapy
- Body Mass Index (BMI) of 35 Kg/m2 or greater
- Known allergies to protein products (horse or bovine serum, or porcine trypsin) used in the cell production process
- Known HIV, syphilis at time of screening
- Known active Hepatitis B, or Hepatitis C infection at the time of screening
- 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)
- In the opinion of the investigator, the subject is unsuitable for cellular therapy
- 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)
- Subjects who are legally detained in an official institute
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité Universitätsmedizin Berlin
Berlin, State of Berlin, 10117
About this study
Official title: A Phase I/II, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Intramuscular Injections of Allogeneic PLX-PAD Cells for the Regeneration of Injured Gluteal Musculature After Total Hip Arthroplasty
Local administration of PLX-PAD single dose, intra-muscular injection for the regeneration of injured gluteal musculature after Total Hip Arthroplasty (THA).
Read the detailed 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.
- Conditions
- Total Hip Arthroplasty, Muscle Injury
- Being tested
- 150M PLX-PAD, 300M PLX-PAD, Placebo
- Keywords
- THA, Muscle injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
150M PLX-PADBiological
Single course, multiple IM injections
300M PLX-PADBiological
Single course, multiple IM injections
PlaceboBiological
Single course, multiple IM injections
| Study group | Role | What they receive |
|---|---|---|
| 150M PLX-PAD | Experimental | Single course, multiple IM injections Receives: Biological: 150M PLX-PAD |
| 300M PLX-PAD | Experimental | Single course, multiple IM injections Receives: Biological: 300M PLX-PAD |
| Placebo | Placebo comparator | Single course, multiple IM injections Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0 to Week 26
Secondary outcomes (4)
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.
Measured: Day 0 to Week 26
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.
Measured: Day 1 to Week 12
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
Measured: Day 0 to Week 26
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)
Measured: Day 0 to Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2013
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pluristem Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carsten Perka, MD, Principal investigator, Charité Universitätsmedizin Berlin, Dept. Of Orthopedic Surgery, Charitéplatz 1, 10117 Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01525667
- Sponsor's protocol ID
- PLX-PAD 1301-01
- Status last verified
- Jan 2015
- First submitted
- 31 Jan 2012
- Last updated
- 21 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Intramuscular Injections of Allogeneic PLX-PAD Cells for the Regeneration of Injured Gluteal Musculature After Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT01525667
- Acronym / sponsor ID
- PLX-PAD 1301-01
- Conditions
- Total Hip Arthroplasty, Muscle Injury
- Keywords
- THA, Muscle injury
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Pluristem Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 3 Feb 2012 (estimated)
- Results
- Posted 23 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Local administration of PLX-PAD single dose, intra-muscular injection for the regeneration of injured gluteal musculature after Total Hip Arthroplasty (THA).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 150M PLX-PAD | Experimental | Biological: 150M PLX-PADSingle course, multiple IM injections |
| 300M PLX-PAD | Experimental | Biological: 300M PLX-PADSingle course, multiple IM injections |
| Placebo | Placebo comparator | Biological: PlaceboSingle course, multiple IM injections |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects between 50 to 75 years of age
- Scheduled THA
- ASA Score ≤ 3
- Signed written informed consent
Key exclusion criteria (20 listed)
- Muscle diseases
- Severe neurological diseases
- Opioid long term medication
- Pain chronification > stadium II of Gerbershagen
- Immunosuppression due to illness or medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 150M PLX-PADSingle course, multiple IM injections | Biological | 150M PLX-PAD |
| 300M PLX-PADSingle course, multiple IM injections | Biological | 300M PLX-PAD |
| PlaceboSingle course, multiple IM injections | Biological | Placebo |
Primary outcome
Change From Day 0 to Week 26 in the Maximal Voluntary Isometric Contraction (MVIC) Moment of the Injured Side to Assess Gluteus Medius Strength.
Time frame: Day 0 to Week 26
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.
4 secondary outcomes
Change From Day 0 to Week 26 in Muscle Volume.
Time frame: Day 0 to Week 26
Change From Day 1 to Week 12 in Mean Fiber Diameter.
Time frame: Day 1 to Week 12
Change From Day 0 to Week 26 in the Ratio of Injured to Contralateral Pelvic Shift .
Time frame: Day 0 to Week 26
Change From Day 0 to Week 26 in the Visual Analog Scale (VAS) Pain Score.
Time frame: Day 0 to Week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carsten Perka, MD principal investigator
Charité Universitätsmedizin Berlin, Dept. Of Orthopedic Surgery, Charitéplatz 1, 10117 Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 150M PLX-PAD and 300M PLX-PAD in people with Total Hip Arthroplasty and Muscle Injury, run by Pluristem Ltd. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Day 0 to Week 26 in the Maximal Voluntary Isometric Contraction (MVIC) Moment of the Injured Side to Assess Gluteus Medius Strength. (time frame: Day 0 to Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2015.