Health Trials

Stem Cell Study in Osteoarthritis of the Knee and Hip Joints

ConditionOsteoarthritis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-95
SponsorGrigory Karmy

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bone Marrow Aspirate, Lipoaspirate Concentrate

    Biological/Vaccine

    Autologous Cell Therapy.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Knee arm randomized to Lipoaspirate Concentrate and Bone Marrow AspirateActive comparator 1 intervention
Group B: Hip Arm randomized to Lipoaspirate Concentrate and Bone Marrow AspirateActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
360 days

Secondary outcomes

1

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

Time frame
90, 180 days
2

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

Time frame
90, 180, 360 days
3

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

Time frame
90, 180, 360 days
4

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

Time frame
90, 180, 360 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Grigory Karmy

Lead sponsor

Dr. G. Karmy Medicine Professional Corporation

Sponsor institution

Source ClinicalTrials.gov
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