A Phase I, randomised, double blind, placebo-controlled, single ascending dose study to evaluate the safety and tolerability of allogeneic adipose-derived mesenchymal stem cells injected into patients with osteoarthritis of the knee.

A Phase I, single centre, randomised, double blind, placebo-controlled, single ascending dose (SAD) study to evaluate the safety and tolerability of allogeneic adipose-derived mesenchymal stem cells (MAG200) administered by intra-articular injection to patients with symptomatic osteoarthritis of the knee.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617001095358

Enrollment

Registered

2017-07-27

Start date

2018-07-02

Completion date

2019-02-01

Last updated

2024-08-19

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 Phase I, dose escalation trial will evaluate the safety and tolerability of Magellan Biologicals’ allogeneic (obtained from a donor) adipose-derived mesenchymal stem cells (MAG200) when injected into the knees of patients with osteoarthritis of the knee. This is the first time MAG200 will be given to human subjects who are not genetically related to the donor of the stem cells. Up to 40 volunteers aged between 18-65 years, will be enrolled. A maximum of four dose levels of MAG200 will be tested with 10 subjects in each dose level cohort; 8 subjects receiving MAG200 and 2 receiving placebo. The subjects and study team will not know which treatment a subject receives. Dosing will commence at the lowest dose level of MAG200 and a Safety Review Team will review the safety data of each dose level cohort before allowing progression to the next dose level to occur.

Interventions

The Investigational Product MAG200 is a preparation of allogeneic human adipose-derived mesenchymal stem cells (MSCs) in sterile, clinical grade injectable isotonic solution. Participants will receive a single dose of Investigational Product (MAG200 / placebo) which will be administered by intra-articular injection into the study knee. Up to 40 eligible subjects will be randomised into the study in four sequential cohorts. Each cohort will comprise 10 subjects, who will be randomised in a 4 to 1 ratio to active or placebo treatment arms (i.e. 8 active: 2 placebo). Dosing will commence at the lowest dose level of MAG200. An internal Safety Review Team (SRT) will be established to review safety data of the previous cohort to determine if dose escalation to the next dose level is recommended. A maximum of 4 dose levels of MAG200 will be studied: 10 million cells, 20 million cells, 50 million cells and 100 million cells.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

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

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

i) Body mass index BMI must be 'greater than or equal' to 19.0 kg/m2 and 'less than or equal to' 35.0 kg/m2; ii) A documented diagnosis of osteoarthritis (Grade 2 or Grade 3) of the study knee

Exclusion criteria

i) MRI-confirmed displaced meniscal tear, ligament deficiency or generalised Grade 4 chondral loss in the study knee. ii) History of or suspected infective or inflammatory joint disorders. iii) Joint surgery within 3 years prior to study start. iv) Females who are pregnant or planning a pregnancy during the following 12 months. v) Any contraindication to intra-articular injection. vi) Any contraindication to an X-ray or MRI of the study knee.

Outcome results