Stem Cell Study in Osteoarthritis of the Knee and Hip Joints

NCT05507099 | Recruiting Phase 2

• 1 other identifier: 01
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is the change from the Baseline to the Day 360 in WOMAC pain subscale pain subscale

  360 days

Secondary Outcomes (6)

• Change from Baseline to Days 90, 180 in WOMAC pain subscale

  90, 180 days

• Change from Baseline to Days 90, 180, and 360 in WOMAC stiffness subscale

  90, 180, 360 days

• Change from Baseline to Days 90, 180, and 360 in WOMAC function subscale

  90, 180, 360 days

• Change from Baseline to Days 90, 180, and 360 in total WOMAC score

  90, 180, 360 days

• Change from Baseline to Days 90, 180, and 360 in Patient's Global Impression of Changes (PGIC)

  90, 180, 360 days

Study Arms (2)

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.

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.

Biological: Bone Marrow Aspirate, Lipoaspirate Concentrate

Interventions

Bone Marrow Aspirate, Lipoaspirate Concentrate BIOLOGICAL

Autologous Cell Therapy.

Hip Arm randomized to Lipoaspirate Concentrate and Bone Marrow Aspirate; Knee arm randomized to Lipoaspirate Concentrate and Bone Marrow Aspirate

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Grigory Karmy: lead

Study Sites (1)

Karmy Clinic

Brampton, Ontario, L6V 1B4, Canada

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Grigory Karmy, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grigory Karmy, MD

CONTACT

905 278 5158; grigmed66@gmail.com

Maimuna F Ahmed, MBBS

CONTACT

905 278 5158; maimuna@karmyclinic.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Qualified Investigator

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 18, 2022
• Study Start: August 23, 2022
• Primary Completion (Estimated): August 8, 2028
• Study Completion (Estimated): August 8, 2028
• Last Updated: March 5, 2025

Record last verified: 2025-03

Locations

CA (1)