OsteoarthritisPhase 2NCT05507099
Stem Cell Study in Osteoarthritis of the Knee and Hip Joints
A Phase 2 study testing Bone Marrow Aspirate, Lipoaspirate Concentrate in people with Osteoarthritis, run by Grigory Karmy at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Bone Marrow Aspirate, Lipoaspirate Concentrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteCanada
- Study dates
- 23 Aug 2022to 8 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 18 to 95 years old
- Residents of Canada
- Written informed consent 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
- 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).
- Diagnosis of symptomatic knee or hip osteoarthritis for at least 12 weeks prior to screening based on an X-ray performed within 1 year prior to screening period.
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- 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
- bracing
- cortisone injections,
- hyaluronic acid injections,
- dextrose injections (prolotherapy)
- platelet-rich plasma injections
- Women of childbearing potential must use an effective method of contraception from 14 days prior to baseline visit to 360 days after intervention. Effective birth control 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.
- Body mass index (BMI) ≤ 50 kg/m2
Who cannot join
- 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 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.
- History of malignancy except for the diagnosis of basal cell carcinoma, within 5 years prior to pre-screening.
- 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
- Prior arthroscopic or open surgery of the index joint within 6 months prior to screening
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- Planned arthroscopic or open surgery of the index joint during study period
- 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 visit
- Know hypersensitivity to lidocaine, epinephrine or heparin
- History of coagulopathy
- Fever (forehead temperature above 38.0 centigrade) at baseline visit
- Subjects with cutaneous infection at the lipoaspirate or bone marrow aspirate site 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 investigator believes makes the patient unsuitable for the study
- Subjects using warfarin before the screening, with an INR above 3
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Karmy Clinic
Brampton, Ontario, L6V 1B4
Grigory Karmy, MD, 905 278 5158, grigmed66@gmail.com
Melissa Butcher, 905 278 5158, queenstreetmedical@hotmail.com
About this study
Official title: 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
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.
Read the detailed description
The primary objective is to compare of magnitude and duration of pain relief of intra-articular injections with Lipoaspirate Concentrate vs Bone Marrow Aspirate.
The secondary objective is to compare the effect of Lipoaspirate Concentrate vs Bone Marrow Aspirate intra-articular injections on functional improvement, stiffness, global impression of change, and consumption of analgesic medication.
The exploratory objective is to explore the safety and the general tolerability of a single intra-articular injection of Lipoaspirate Concentrate vs Bone Marrow Aspirate.
- Conditions
- Osteoarthritis
- Being tested
- Bone Marrow Aspirate, Lipoaspirate Concentrate
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Marrow Aspirate, Lipoaspirate ConcentrateBiological
Autologous Cell Therapy.
| Study group | Role | What they receive |
|---|---|---|
| Knee arm randomized to Lipoaspirate Concentrate and Bone Marrow Aspirate | Active comparator | The Subjects will be randomized to one of the treatment groups separately for the knee and hip arms of the study. Group A will receive a single intra-articular injection with lipoaspirate concentrate to the knee and Group B will receive a single intra-articular injection with bone marrow aspirate concentrate. Receives: Biological: Bone Marrow Aspirate, Lipoaspirate Concentrate |
| Hip Arm randomized to Lipoaspirate Concentrate and Bone Marrow Aspirate | Active comparator | The subjects will be randomized to one of the treatment groups separately for the knee and hip arms of the study. Groups C will receive a single intra-articular injection with lipoaspirate concentrate to the hip and Group D will receive a single intra-articular injection with bone marrow aspirate. Receives: Biological: Bone Marrow Aspirate, Lipoaspirate Concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the change from the Baseline to the Day 360 in WOMAC pain subscale pain subscale
Measured: 360 days
Secondary outcomes (6)
Change from Baseline to Days 90, 180 in WOMAC pain subscale
Measured: 90, 180 days
Change from Baseline to Days 90, 180, and 360 in WOMAC stiffness subscale
Measured: 90, 180, 360 days
Change from Baseline to Days 90, 180, and 360 in WOMAC function subscale
Measured: 90, 180, 360 days
Change from Baseline to Days 90, 180, and 360 in total WOMAC score
Measured: 90, 180, 360 days
Change from Baseline to Days 90, 180, and 360 in Patient's Global Impression of Changes (PGIC)
Measured: 90, 180, 360 days
Change in average weekly consumption of analgesic medications from Baseline to Day 90, 180, and 360
Measured: 90, 180, 360 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start23 Aug 2022
- Primary completion8 Aug 2028 (estimated)
- Study completion8 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grigory Karmy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Grigory Karmy, Dr. G. Karmy Medicine Professional Corporation
- Investigators
- Grigory Karmy, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507099
- Sponsor's protocol ID
- 01
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2022
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05507099
- Acronym / sponsor ID
- 01
- Conditions
- Osteoarthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Grigory KarmyUniversity, hospital or other
- Study start
- 23 Aug 2022 (actual)
- Primary completion
- 8 Aug 2028 (estimated)
- Study completion
- 8 Aug 2028 (estimated)
- First posted
- 18 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objective is to compare of magnitude and duration of pain relief of intra-articular injections with Lipoaspirate Concentrate vs Bone Marrow Aspirate.
The secondary objective is to compare the effect of Lipoaspirate Concentrate vs Bone Marrow Aspirate intra-articular injections on functional improvement, stiffness, global impression of change, and consumption of analgesic medication.
The exploratory objective is to explore the safety and the general tolerability of a single intra-articular injection of Lipoaspirate Concentrate vs Bone Marrow Aspirate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Knee arm randomized to Lipoaspirate Concentrate and Bone Marrow Aspirate | Active comparator | Biological: Bone Marrow Aspirate, Lipoaspirate ConcentrateThe Subjects will be randomized to one of the treatment groups separately for the knee and hip arms of the study. Group A will receive a single intra-articular injection with lipoaspirate concentrate to the knee and Group B will receive a single intra-articular injection with bone marrow aspirate concentrate. |
| Hip Arm randomized to Lipoaspirate Concentrate and Bone Marrow Aspirate | Active comparator | Biological: Bone Marrow Aspirate, Lipoaspirate ConcentrateThe subjects will be randomized to one of the treatment groups separately for the knee and hip arms of the study. Groups C will receive a single intra-articular injection with lipoaspirate concentrate to the hip and Group D will receive a single intra-articular injection with bone marrow aspirate. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Male or female, aged 18 to 95 years old
- Residents of Canada
- Written informed consent 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
- 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).
Key exclusion criteria (18 listed)
- 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 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.
- History of malignancy except for the diagnosis of basal cell carcinoma, within 5 years prior to pre-screening.
- 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
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 |
|---|---|---|
| Bone Marrow Aspirate, Lipoaspirate ConcentrateAutologous Cell Therapy. | Biological | Hip Arm randomized to Lipoaspirate Concentrate and Bone Marrow Aspirate, Knee arm randomized to Lipoaspirate Concentrate and Bone Marrow Aspirate |
Primary outcome
The primary endpoint is the change from the Baseline to the Day 360 in WOMAC pain subscale pain subscale
Time frame: 360 days
6 secondary outcomes
Change from Baseline to Days 90, 180 in WOMAC pain subscale
Time frame: 90, 180 days
Change from Baseline to Days 90, 180, and 360 in WOMAC stiffness subscale
Time frame: 90, 180, 360 days
Change from Baseline to Days 90, 180, and 360 in WOMAC function subscale
Time frame: 90, 180, 360 days
Change from Baseline to Days 90, 180, and 360 in total WOMAC score
Time frame: 90, 180, 360 days
Change from Baseline to Days 90, 180, and 360 in Patient's Global Impression of Changes (PGIC)
Time frame: 90, 180, 360 days
Change in average weekly consumption of analgesic medications from Baseline to Day 90, 180, and 360
Time frame: 90, 180, 360 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
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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.
Grigory Karmy, MD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bone Marrow Aspirate, Lipoaspirate Concentrate in people with Osteoarthritis, run by Grigory Karmy at 1 site in Canada.
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 18 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 25 Aug 2026. 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 Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Grigory Karmy, MD (905 278 5158, grigmed66@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is the change from the Baseline to the Day 360 in WOMAC pain subscale pain subscale (time frame: 360 days). 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 25 Aug 2026.