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AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

Mesenchymal stromal cell therapy for rehabilitation after hip fracture.

This study is investigating a new treatment to help older people recover after breaking their hip and having surgery. It's called mesenchymal stromal cell therapy. This type of therapy uses special cells to help the body repair itself. Researchers want to see if giving this therapy to patients who are frail (meaning they might be a bit weaker or have other health problems) can help them heal better, regain their strength, and improve their ability to move around after their hip operation. This is an early-stage study, meaning doctors are carefully checking to see if the treatment is safe and how the body reacts to it, rather than yet focusing on how well it works overall.

At a glance

Status
Authorised
Phase
Human Pharmacology (Phase I)- Other
Sponsor
Karolinska University Hospital
Enrolment target
10
Start
05 May 2025

What is this study about?

When older people break their hip, it often requires surgery, and recovery can be a long and challenging process, especially if they are already a bit frail. This study is exploring a new way to try and help this recovery. It's looking at a special type of treatment called mesenchymal stromal cell therapy.

Mesenchymal stromal cells are natural cells found in our bodies that are known for their ability to help repair damaged tissues and reduce inflammation. In this study, doctors are giving these cells to patients who have had hip fracture surgery, hoping they can boost the body's natural healing process. The main goal right now is to see if this treatment is safe for patients and how their bodies respond to it. If it looks promising, it could lead to better ways to help people get back to their normal lives after a hip fracture.

Finding new ways to improve recovery after hip surgery for older and frailer patients is really important. A successful recovery means less pain, more independence, and a better quality of life. This research could be a step towards finding such improvements.

Key takeaways

  • This study is testing a new cell therapy for hip fracture recovery.
  • It aims to help older, frailer patients heal better after surgery.
  • This is an early-stage study to check safety and how the body reacts.
  • Participation involves monitoring, check-ups, and possibly blood tests.
  • You can withdraw from the study at any time.
  • The treatment might help, but there's no guarantee.

Who may be eligible?

This study is looking for people who have recently had surgery for a hip fracture. It's for older patients who might be considered a bit 'frail,' meaning they might have other health conditions or feel weaker than younger people. Both men and women can take part.

As this is an early-stage study, doctors will need to check carefully to make sure it's suitable and safe for you. They will have specific health checks to make sure you fit the study's requirements.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Have you recently had an operation for a broken hip?
  2. Are you an older adult?
  3. Are you considered 'frail' or less strong than you used to be?
  4. Are you a man or a woman?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the mesenchymal stromal cell therapy after your hip fracture surgery. Doctors would then closely monitor your health and recovery over a period of time. This would involve regular check-ups at the hospital or clinic, where they might ask you questions about how you're feeling, carry out physical examinations, and take some blood samples. The total duration of your participation, including follow-up visits, would be explained to you in detail by the study team. You would have the right to withdraw from the study at any time.

Potential risks and benefits

The potential benefits of taking part in this study are that you might recover better and more quickly from your hip fracture surgery. However, as this is an early-stage study, there's no guarantee the treatment will help you. There might be risks associated with the treatment, such as side effects from the cell therapy or from repeated hospital visits and tests. All potential risks would be fully explained to you. Remember, joining a study like this is always your choice, and you can decide to stop taking part at any time without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Sweden

Common questions

What are mesenchymal stromal cells?

These are special cells from your body that help repair damaged tissues and reduce swelling. Doctors are hoping they can boost healing after hip surgery.

Is this a new treatment?

Yes, this therapy is still being studied. This research is an early step to see if it's safe and how it works in people after hip fractures.

Will I definitely get better if I join?

There's no guarantee. The study is trying to find out if this treatment helps, but it might not work for everyone, or at all.

Who can join this study?

It's for older, sometimes frailer, patients who have recently had surgery for a broken hip. Both men and women are welcome.

Can I stop taking part if I change my mind?

Yes, absolutely. You can withdraw from the study at any time, and it won't affect the care you receive from your doctors.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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