Not yet recruitingPHASE3INTERVENTIONAL

Bone Marrow Aspirate Concentrate (BMAC) Treatment for Knee Osteoarthritis

This study, called ACCELERATE3, is searching for a better way to treat knee arthritis. Researchers are testing a treatment called Bone Marrow Aspirate Concentrate (BMAC). This involves taking a small amount of bone marrow from your hip, processing it, and then injecting it back into your arthritic knee(s). They want to see if this single injection of BMAC is more effective at reducing pain and improving movement than the usual care for knee arthritis. The study will involve 374 people across Canada, aged 40 and older, who have mild to severe knee arthritis. Participants will be followed for 48 weeks (about 11 months) to track their progress.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

CELL Technologies Inc.

Enrolment target

374

Start

01 Sep 2024

Estimated completion

01 Dec 2026

Knee Osteoarthritis Musculoskeletal Diseases

What is this study about?

Knee arthritis, also known as osteoarthritis (OA), is a common condition where the smooth cushion (cartilage) in your knee joint wears down, leading to pain, stiffness, and difficulty moving. It can make everyday activities challenging. This study is exploring a new way to potentially help people with knee arthritis.

The treatment being tested is called Bone Marrow Aspirate Concentrate (BMAC). It uses your body's own cells to help with healing. For patients receiving BMAC, doctors will take a small sample of your bone marrow, usually from your pelvic (hip) bone. This bone marrow contains special cells that are then concentrated and immediately injected directly into your affected knee or knees. Scientists believe these cells might help repair damaged tissues or reduce inflammation in the joint.

The main goal of this study is to compare how well a single BMAC injection works against what's considered standard care for knee arthritis. Researchers will be looking to see if BMAC can reduce pain and improve how well you can use your knee, making daily life easier. This is a "Phase 3" study, which means it's a larger study designed to confirm the treatment's effectiveness and safety before it might become widely available.

Key takeaways

This study is testing a new treatment (BMAC) for knee arthritis.
BMAC involves using your own bone marrow cells.
It aims to reduce pain and improve knee function.
The study compares BMAC to standard care for knee arthritis.
Participation involves regular visits and lasts about 11 months.

Who may be eligible?

To join this study, you need to be at least 40 years old and have a clear diagnosis of knee arthritis in one or both knees. This diagnosis must be confirmed by an X-ray taken within the last six months. Your knee pain should have been bothering you for at least 3 months and not have improved with regular pain medications or other common treatments like physical therapy.

You also need to be able to describe your pain as at least a 4 out of 10 at the start of the study. You must be willing to provide your written permission to take part and be able to communicate effectively with the study team. For women who could become pregnant, a negative pregnancy test will be required.

There are also some reasons you wouldn't be able to join. For example, if you're planning knee replacement surgery within six months, have had knee surgery in the last six months, or have had a partial or total knee replacement before. Other reasons include having a Body Mass Index (BMI) of 30 or higher, or having other conditions that affect your joints, such as rheumatoid arthritis or gout.

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.

Are you 40 years old or older?
Do you have a diagnosis of knee arthritis confirmed by an X-ray within the last 6 months?
Has your knee pain lasted at least 3 months and not improved with other treatments?
Do you have knee pain that you would rate at least a '4 out of 10'?
Are you NOT planning knee replacement surgery in the next 6 months?
Have you NOT had knee surgery in the last 6 months, or had a previous knee replacement?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you might receive either the BMAC treatment or standard care; which one you get is decided by chance, like flipping a coin. If you receive BMAC, a small amount of bone marrow will be gently taken from your hip bone. This is done by a doctor and takes place on the same day as your knee injection. The collected bone marrow is then prepared right away and injected into your knee or knees.

Regardless of which group you're in, you'll be followed closely for about 48 weeks, which is roughly 11 months. During this time, you'll have several scheduled visits where the study team will collect blood samples for testing. They will also keep a close eye on your health and any side effects you might experience. You'll have physical exams and fill out questionnaires about your knee pain, how you're moving, and your overall health. These assessments help the researchers understand how the treatments are working.

Potential risks and benefits

Taking part in any medical study has potential benefits and potential risks. A possible benefit of joining this study is that you might receive a new treatment (BMAC) that could help reduce your knee pain and improve your movement more effectively than current options. However, there's also a chance that the treatment might not work for you, or you might receive the standard treatment. As with any medical procedure, there are potential risks, such as discomfort or bruising from the bone marrow collection or the knee injection, and there's a small risk of infection. All potential risks will be thoroughly explained to you before you agree to participate. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Canadian Centres for Regenerative Therapy (CCRT)
Verified postcode
Toronto, Canada

Common questions

What is knee osteoarthritis?

Knee osteoarthritis is a common joint condition where the protective cartilage in your knee wears away, causing pain, stiffness, and swelling.

What is BMAC treatment?

BMAC stands for Bone Marrow Aspirate Concentrate. It's a treatment where a small amount of your own bone marrow is taken from your hip, processed, and then injected into your knee to help with healing.

How long will the study last?

If you join, you'll be followed for about 48 weeks, which is roughly 11 months, to check on your progress.

Will I know if I get BMAC or standard care?

No, whether you receive BMAC or standard care is chosen randomly. This helps researchers fairly compare the results of both groups.

What if I decide I don't want to continue?

You are free to leave the study at any point, and your decision will not affect your regular medical care.

How to find out more

Riam Shammaa, MD

info@celltechnologies.net 437-985-1505 Official trial record

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