A Study of Experimental PLX-PAD Cells for the Treatment of Muscle Injury After Arthroplasty for Hip Fracture

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Age: 60 to 90 years old
Gender:
Any
Healthy Volunteers: No
Keywords: hip fracture, hip surgery, hip arthroplasty
Type: Drug study, Phase 3
Target:
10 Participants
Investigator:
Description
This study hopes to learn if the experimental medicine PLX-PAD is effective and safe to treat muscle injury after hip surgery. It will be compared to placebo (a drug that looks like the study drug but has no effect). During surgery after hip fracture, further muscle injury usually occurs. This muscle injury is in addition to the initial muscle injury caused by the hip fracture itself. Further muscle injury may cause loss of muscle mass and strength. It can lead to reduced mobility after recovering from the hip surgery. There is currently no treatment to improve the recovery of the muscle after a hip surgery.

PLX-PAD is a cellular therapy. This means that it contains living cells which are injected into the patient’s muscles. These cells come from a human placenta. The cells are collected during a planned cesarean section from healthy female volunteers who donated it.

All donors of the placenta complete a comprehensive questionnaire. It asks about their risk of being infected or being a carrier of infectious diseases. Their blood is tested for a vast panel of infectious diseases. Since this research uses human cells, the process for obtaining the cells and preparing them for use is subject to the highest standards.

Cells in PLX-PAD respond to stress signals from tissues that have been damaged. Although it is not proven, it is thought that PLX-PAD cells injected into the injured muscle during the surgery can improve muscle function after surgery. This improves recovery after surgery for hip fracture.

The placebo contains just the fluid with dimethyl sulfoxide (DMSO), human serum albumin (human blood protein) and PlasmaLyte (salts solution), but does not contain the PLX-PAD cells.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion criteria:

  1. Male or female subjects.
  2. Subjects 60 to 90 years of age
  3. Subjects suffering low energy trauma with intracapsular neck of femur fracture.
  4. Planned to be treated with total hip arthroplasty (THA) or hemi-arthroplasty (HA) within 48 hours of hospital admission and 72 hours post fracture.
  5. Subjects able to walk 10 feet/3 meters before the fracture.
  6. Signed an informed consent.

Exclusion criteria:

    1. Any significant musculoskeletal, neurologic or neuromuscular disease causing muscle weakness and/or affecting mobility 2. Current fracture is due to bone pathology other than osteoporosis or due to major trauma 3. Planned orthopedic surgery on lower limbs (excluding hip arthroplasty) within the next 12 months.
  • Diabetes mellitus with HbA1c >10% at Screening. 5. Known current or history of proliferative retinopathy or diabetic retinopathy.
  • Known active Hepatitis B virus or Hepatitis C virus infection. 7. Known human immunodeficiency virus (HIV) infection 8. Subjects on renal replacement therapy or with estimated glomerular filtration rate (eGFR) <15 mL/min/1.73m2 9. Severe congestive heart failure symptoms (New York Heart Association [NYHA] Stage IV).
  • Known uncontrolled severe hypertension. 11. Treatment with anabolic steroids within 6 months prior to study start 12. Active malignancy or history of malignancy within 3 years prior to study start 13. Known moderate to severe dementia or severe psychiatric disorder. 14. Known allergies to any of the following: dimethyl sulfoxide (DMSO), human serum albumin (HSA), bovine serum albumin, PlasmaLyte.
  • History of allergic/hypersensitivity reaction to any substance having required hospitalization and/or treatment with IV steroids/epinephrine 16. Pulmonary disease requiring supplemental oxygen treatment on a daily basis. 17. life expectancy of less than 6 months, for reasons other than HF complications, 18. 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).
  • In the opinion of the Investigator, the subject is unsuitable for participating in the study.
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
If you agree to take part in this research study, we will compensate you $50.00 for your time and effort to complete the following visits: Screening (V0), Treatment (V1), Day 1 (V2), Day 5 (V3), Week 6 (V4), Week 12 (V5), Week 26 (V6), and Week 52 (V7). Payment will be sent to you by check in the mail with in 4-6 weeks after completing each visit listed. You will only be compensated for the visits listed that you complete. You could be compensated up to $400.00 once you complete the study.
Resources
Schedule
Study duration and period
You will be in this study for about 2 years. You will need to visit the research site about 4 times after your hospitalization for your hip surgery.
Recruitment period
From March 15, 2019
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Karen O'Donnell
Research Topic
Conditions:
  • Hip Fracture