HiQCell TM Joint Registry in patients with osteoarthritis following the HiQCellTM procedure. (This is not a clinical trial - patients undergoing the treatment as prescribed by their specialist are followed up post-procedure.)

A Registry of Autologous Non-Expanded Adipose Derived Stem Cells (HiQCellTM) in the Treatment of Osteoarthritis to determine prevalence of joint infections.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12612000672853

Enrollment

403

Registered

2012-06-22

Start date

2011-03-31

Completion date

2014-05-30

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 is an observational registry to assess the long-term safety and efficacy of the HiQCell procedure in patients who have been prescribed the procedure to treat joint arthritis following a registered medical specialist consultation.

Interventions

This is an observational registry. All patients referred to one of Regeneus’ HiQCellTM Specialist Centres who have OA in one or more joints who fulfil the inclusion and exclusion criteria are eligible for inclusion. Long-term (5 year) follow up outcomes will be assessed using patient and clinician reported standard questionnaires.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Received a HiQCellTM procedure for joint osteoarthritis Grade 2, 3 or early Grade 4 Osteoarthritis Concurrent disease medically stable

Exclusion criteria

Established Grade 4 osteoarthritis Major mal-alignment Large osteophytes Bone on Bone Obese Known allergies/ hypersensitivities to local anaesthetics or antibiotics Anti-coagulant use (as below) that cannot be stopped or bleeding disorders (no use of Warfarin, Aspirin, Vitamin E, fish oil or anti-inflammatory medications 10 days before treatment) Immunosuppression Pregnancy

Outcome results