Testing Bone Marrow Aspirate, Lipoaspirate for osteoarthritis
Official title: Stem Cell Study in Osteoarthritis of the Knee and Hip Joints
A Phase 2, Randomized Study to Compare Bone Marrow Aspirate Versus Lipoaspirate Concentrate Autologous Cell Therapy for the Treatment of the Knee and Hip Osteoarthritis in Adults
- Phase 2
- 2 groups
- One site, in Brampton
- Recruiting
Interventions
- Biological therapy
Bone Marrow Aspirate, Lipoaspirate Concentrate
Autologous Cell Therapy.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Karmy Clinic
Brampton, Ontario
Eligibility Criteria
See who this study is looking for35 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Male or female, aged 18 to 95 years old
- +The NRS for at least 5 daily measures will be used to calculate the average score. An average NRS pain score 4-9 (moderate to severe pain).
- +Residents of Canada
- +Written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → to participate in the study
- +Willingness and ability to comply with the study procedures and phone visit schedules and ability to follow verbal and written instruction
- +Diagnosis of symptomatic knee or hip osteoarthritis for at least 12 weeks prior to screeningScreeningThe checks done before joining, to see whether a study fits.Read more → based on an X-ray performed within 1 year prior to screening period.
- +Radiographic evidence of OA of the index knee or hip (Kellgren-Lawrence Grade I to IV) within 1 year prior to screening or during the screening period.
- +Failed conservative treatment for more than 12 weeks before the screening, meaning that pain persists for more than 12 weeks after the patient tried two or more of the following medication or interventions in that period.
- +oral analgesics, including over-the-counter medications and supplements,
- +physiotherapy
- +acupuncture
- +cortisone injections,
- +hyaluronic acid injections,
- +dextrose injections (prolotherapy)
- +platelet-rich plasma injections
- +Body mass index (BMI) ≤ 50 kg/m2
- +Women of childbearing potential must use an effective method of contraception from 14 days prior to baseline visitBaselineYour starting measurements, taken before treatment begins.Read more → to 360 days after intervention. Effective birth controlControl groupThe group a new treatment is measured against.Read more → considered for this trial are total abstinence; consistent use of birth control pills; injectable birth control methods; intrauterine device placement; and tubal ligation or male partner with vasectomy; diaphragm with contraceptive jelly or condom with contraceptive foam.This does not apply to male and postmenopausal women.
Exclusion
- −Know hypersensitivity to lidocaine, epinephrine or heparin
- −History of malignancy except for the diagnosis of basal cell carcinoma, within 5 years prior to pre-screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- −Presence of retained rods or screws or insertion or joint replacement in the joint to be injected
- −History of autoimmune diseases including lupus and rheumatoid arthritis
- −Intra-articular injections in the index joint within 3 months prior to screening for corticosteroids or dextrose injections, and within 6 months prior to screening for hyaluronic acid or platelet-rich plasma (PRP) injections
- −Use of systemic immunosuppressives, immunomodulators or chemotherapeutic agents within 3 months prior to baseline visitBaselineYour starting measurements, taken before treatment begins.Read more →
- −History of coagulopathy
- −Fever (forehead temperature above 38.0 centigrade) at baseline visit
- −Subjects with cutaneous infection at the lipoaspirate or bone marrow aspirate siteTrial siteA hospital or clinic where a study is actually run.Read more → and/or in the area of the injection at baseline visit
- −Subjects with hemoglobin less than 10 g/L
- −Subjects with platelet count less than 155x109/L
- −Subjects participating in a study of an experimental drug or medical device within 30 days of study entry
- −Any medical condition the qualified investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → believes makes the patient unsuitable for the study
- −Subjects using warfarin before the screening, with an INR above 3
- −Women who are pregnant or planning to become pregnant during the trial period.
- −Women of childbearing potential (not surgically sterile or post-menopausal for at least one year) not using a highly effective method of contraception such as total abstinence; consistent use of birth controlControl groupThe group a new treatment is measured against.Read more → pills; injectable birth control methods; intrauterine device placement; and tubal ligation or male partner with vasectomy; diaphragm with contraceptive jelly or condom with contraceptive foam.
- −Prior arthroscopic or open surgery of the index joint within 6 months prior to screening
- −Planned arthroscopic or open surgery of the index joint during study period
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Groups A and B, the comparison group, receive Bone Marrow Aspirate, Lipoaspirate Concentrate.
Registry label: A: Knee arm randomized to Lipoaspirate Concentrate and Bone Marrow Aspirate · B: Hip Arm randomized to Lipoaspirate Concentrate and Bone Marrow Aspirate
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 95 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 400 people.
The study is currently expected to finish around August 2028.
The main measurement is taken over: 360 days.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
The primary endpointPrimary endpointThe single main question the study is designed to answer.Read more → is the change from the BaselineBaselineYour starting measurements, taken before treatment begins.Read more → to the Day 360 in WOMAC pain subscale pain subscale — measured over 360 days.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05507099 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Bone Marrow Aspirate, Lipoaspirate ConcentrateBiological
Autologous Cell Therapy.
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 95 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 95 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 360 days.
The study as a whole is currently expected to finish around 2028-08-08.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 400 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Brampton, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The purpose of this trial is to compare the effect of a single intra-articular injection of Lipoaspirate Concentrate vs Bone Marrow Aspirate on pain reduction and functional improvement in the treatment of the knee and hip OA.
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.