Trials Sponsors Conditions Drugs Pricing

Conditions

Knee Osteoarthritis Musculoskeletal Diseases

Keywords

Bone Marrow Aspirate Concentrate (BMAC)Bone Marrow Aspirate (BMA)AutologousPhase 3RandomizedInterventional

Outcome Measures

Primary Outcomes (1)

WOMAC® Pain Subscore
To assess the efficacy of a single intra-articular (IA) injection of autologous BMAC, in one or both knees, compared to single IA injection of Standard of Care (SOC) in patients with mild to severe knee osteoarthritis (OA). The Western Ontario and McMaster Universities Arthritis Index (WOMAC) questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Possible score range of 0-20 for Pain (Higher scores = worse outcome).
Change in WOMAC® Pain Subscore (Section A, Items #1-5) as measured by VAS from Baseline to the end of Week 12.

Secondary Outcomes (9)

Safety (Baseline to Day 30 post IA injection)
Incidence and severity of immediate adverse events (AEs) for 30 minutes following IA injection; Incidence and severity of any AE for 30 days following IA injection; Incidence of Serious Adverse Events (SAEs)
WOMAC® Physical Function Subscore
Change in WOMAC® Physical Function Subscore (Section C, Items #8-24) as measured by VAS from Baseline to the end of Week 12.
WOMAC® Pain Subscore
Percentage of subjects classified as 'responders' as measured by improvement in WOMAC® Pain Subscore at Week 12
WOMAC® Physical Function Subscore
Percentage of subjects classified as 'responders' as measured by improvement in WOMAC® Physical Function Subscore at Week 12
WOMAC® Physical Function and Pain Subscore
Percentage of subjects classified as 'responders' as measured by a composite responder analysis at Week 12.

Other Outcomes (6)

Exploratory - Economic
To determine the effect of IA injection(s) of autologous BMAC in promoting health economic outcomes, compared to controls
Exploratory - WOMAC® Pain Subscore
Change from baseline in WOMAC® Pain Subscore (Section A, Items #1-5) as measured by VAS at 24, 36, and 48-weeks
Exploratory - WOMAC® Physical Function Subscore
Change from baseline in WOMAC® Physical Function Subscore (Section C, Items #8-24) as measured by VAS at 24, 36, and 48-weeks
+3 more other outcomes

Study Arms (2)

Standard of Care

NO INTERVENTION

Standard of care IA injection may include cortisone or hyaluronic acid (HA) as per discretion of the Principal Investigator

Bone Marrow Aspirate Concentrate (BMAC)

EXPERIMENTAL

Cell suspension for infusion. 50 mL of Bone Marrow Aspirate collected, and 10-15 mL BMAC injected to knee(s)

Biological: Autologous Bone Marrow Aspirate Concentrate

Interventions

Autologous Bone Marrow Aspirate ConcentrateBiological

Range of between 18.7 X 104 cells/mL and 21.8 X 106 cells/mL total nucleated cells (TNC)

Also known as: BMAC

Bone Marrow Aspirate Concentrate (BMAC)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age40 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female subjects ≥ 40 years old.
The subject must have a clinical diagnosis of osteoarthritis (OA) of one or both knees supported by radiological evidence (Kellgren Lawrence Grade II-IV) which is assessed locally (x-rays within the past 6 months of screening are acceptable).

Sponsors & Collaborators

CELL Technologies Inc.
Industrylead

Study Sites (1)

Canadian Centres for Regenerative Therapy (CCRT)

Toronto, Ontario, Canada

Riam ShammaaCONTACT

MeSH Terms

Conditions

Osteoarthritis, KneeMusculoskeletal Diseases

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesRheumatic Diseases

Study Officials

Riam Shamma, MD
CELL Technologies Inc.
PRINCIPAL INVESTIGATOR

Central Study Contacts

Riam Shammaa, MD

CONTACT

437-985-1505 info@celltechnologies.net

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 14, 2023

First Posted

January 22, 2024

Study Start

September 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

August 2026

Bone Marrow Aspirate Concentrate (BMAC) Treatment for Knee Osteoarthritis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Other Outcomes (6)

Study Arms (2)

Standard of Care

Bone Marrow Aspirate Concentrate (BMAC)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Other Outcomes (6)

Study Arms (2)

Standard of Care

Bone Marrow Aspirate Concentrate (BMAC)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations