The evaluation of allogeneic adipose derived mesenchymal stem cells as a treatment for symptomatic knee osteoarthritis, specifically evaluating safety, effects on knee pain, function and structure, and quality of life in knee osteoarthritis patients.

A Phase 1 Randomised, Double Blind, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Intra-articular Progenza (PRG) in Adults with Symptomatic Knee Osteoarthritis

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000439549

Acronym

The STEP Trial (Safety, Tolerability and Efficacy of Progenza)

Enrollment

Registered

2015-05-07

Start date

2015-07-24

Completion date

2016-03-29

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study examines the safety and tolerability of Progenza, a stem cell product derived from a single donor, for the treatment of knee osteoarthritis. Progenza is injected once into the knee. There is a 1 in 5 chance of receiving placebo, which contains no stem cells. The study will investigate the effect of Progenza on knee pain, function and cartilage integrity. Quality of life and activity level will also be examined over the course of the study.

Interventions

Progenza (PRG) is composed of in vitro expanded mesenchymal stem cells (MSCs) derived from human donor adipose tissue, frozen in vials ready to inject. PRG will be administered in a single, once only, intra-articular injection into the knee of PRG. Two doses of PRG are being used in this trial. Patients will be randomised to receive a single injection into the knee of either 3.9 million cells or 6.7 million cells or placebo. Participants will have follow up assessments out to 12 months post in

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

40 Years to 65 Years

Healthy volunteers

Inclusion criteria

Patients will be eligible to participate if they: - are between 40 and 65 years of age inclusive - have Kellgren-Lawrence grade 1, 2 or 3 symptomatic knee osteoarthritis. - have moderate to severe knee pain associated with OA

Exclusion criteria

Patients will not be eligible to participate if they: - have OA in the non-study knee that has worse pain than the study knee - have had joint surgery in the past 3 years - have major mechanical issues in the study knee - have significant OA in other major joints

Outcome results