Autologous BMA vs Saline and LAM + LP-PRP vs Saline Evaluations in Knee OA

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

148

Participants

Timeline

Start Date

January 1, 2025

Primary Completion Date

June 30, 2026

Study Completion Date

December 31, 2026

Conditions
Osteoarthritis, Knee
Interventions
BIOLOGICAL

Bone Marrow Aspirate (BMA): Minimally manipulated autologous cellular preparation

Participants will undergo a bone marrow aspiration. About 10 mL of BMA will be collected from the posterior iliac spine i.e., ipsilateral and/or contralateral iliac crest using the Cervos Marrow Cellution™ kit. The BMA does not require processing using a centrifuge after collection. 9 mL (or less) of BMA is injected into the osteoarthritic knee joint after collection (Arm A, Study 1).

OTHER

Saline (Placebo Comparator for BMA)

Participants will undergo a bone marrow aspiration to collect about 10 mL of BMA from the posterior iliac spine i.e., ipsilateral and/or contralateral iliac crest. However, 0.9% sodium chloride (NaCl) Baxter or equivalent (9 mL) is injected into the osteoarthritic knee joint (Arm C, Study 1).

BIOLOGICAL

Lipoaspirate Micronized + Leukocyte-Poor Platelet-Rich Plasma (LAM + LP-PRP): Minimally manipulated autologous cellular preparations

Participants will undergo a lipoaspiration. 40 mL of lipoaspirate (LA) will be collected from subcutaneous adipose tissue. LA will be processed using the Cervos LIPO-PRO™ kit and a centrifuge. Participants will also undergo a blood draw. About 30 mL of whole blood will be collected from the antecubital fossa. Whole blood will be processed using the Cervos KEYPRP kit and a centrifuge. After processing, 9 mL (or less) of LAM is injected first followed immediately by 2 mL (or less) of LP-PRP into the osteoarthritic knee joint (Arm B, Study 2).

OTHER

Saline (Placebo Comparator for LAM + LP-PRP)

Participants will undergo a lipoaspiration to collect 40 mL of LA and a blood draw to collect about 30 mL of whole blood. However, 0.9% of sodium chloride (NaCl) Baxter or equivalent is injected twice (9 mL + 2 mL) into the osteoarthritic knee joint (Arm D, Study 2).

Trial Locations (2)

M5S 1B2

NOT_YET_RECRUITING

Women's College Hospital, Toronto

M5T 2S8

RECRUITING

Toronto Western Hospital, University Health Network, Toronto

All Listed Sponsors
collaborator

Women's College Hospital

OTHER

lead

University Health Network, Toronto

OTHER