Clinical Trials

 

Clinical trials are an important step in obtaining regulatory approval for new treatments. Participants volunteer to receive the experimental treatment and are observed closely to determine its effects.

Orthocell's clinical trials are conducted in compliance with the the International Conference on Harmonisation Guidelines for Good Clinical Practice(ICH/GCP). GCP is an international ethical and scientific quality standard for designing, conducting and reporting studies that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and wellbeing of study subjects are protected, and that the clinical trial data are credible.

All clinical trials conducted by Orthocell are listed on international clinical trial registries.

Participating in a Clinical Trial

We currently have a range of clinical trials open for recruitment. Our team comprises of specialist surgeons, sports physicians, physiotherapists, study coordinators, scientists, and nurses. We are an experienced team committed to patient care and are passionate about research. 

Clinical trials that are recruiting participants:

  1. Surgical repair of rotator cuff tear

  2. Hip cartilage defect repair

  3. Upper limb nerve repair

  4. Tennis elbow

  5. Partial rotator cuff tear (in collaboration with Johnson & Johnson)

If you or a member of your family would like to be considered for participation in a clinical trial, please contact us.


Current clinical trial studies  

Listing correct as of (9/01/2019)

Product # Indication Study Title Status

CelGro®

1

Dental Bone and Soft Tissue Regeneration (Dental Implants)

Case series study of CelGro® membrane in guided bone regeneration around exposed dental implants.

Recruitment Closed

2

Surgical repair of rotator cuff tear

Case series study of CelGro® collagen membrane to augment surgical repair of rotator cuff tendinopathy and tear.

Recruiting

3

Hip cartilage defect repair

Case series study: treatment of osteochondral defects in the hip using microfracture augmented with CelGro® collagen matrix.

Recruiting

4

Peripheral nerve injury

Case series study: surgical repair of peripheral nerve injury with CelGro® collagen scaffold.

Recruiting

Ortho-ATI®

5

Tennis elbow

An open label, randomised study of Ortho-ATI versus surgery for treatment of severe, chronic, resistant lateral epicondylitis.

Recruiting

6

Partial rotator cuff tear

Defining a randomised, controlled study of Ortho-ATI® vs corticosteroid injection for rotator cuff tendinopathy and tear.

Recruiting

Study Details

CelGro®

1. A pilot study of CelGro® collagen membrane in guided bone regeneration around exposed dental implants.

Status: Patient recruitment closed

Dental implants are used to replace missing teeth, and are anchored in the jawbone. Guided bone regeneration (GBR) is a technique used to assist the body to grow new bone if there is not enough to safely support the implant. Bone grafting material is packed around the implant and covered over with a collagen membrane. The collagen membrane allows fluids and nutrients through to nourish the new bone, and stops the quicker healing gum tissue from invading the area where the new bone is forming. In this study, CelGro® will be used as the collagen membrane in 20 patients receiving dental implants with guided bone regeneration.

For further information about this trial, please visit the Australia and New Zealand Clinical Trials Registry

2. Case series study of CelGro® collagen membrane to augment surgical repair of rotator cuff tendinopathy and tear.

Status: Recruiting patients

The rotator cuff is a group of muscles and tendons surrounding the shoulder that help move the arm and also keep the head of the humerus (upper arm bone) in the shoulder socket. Injuries to the rotator cuff tendons can be very slow to heal naturally, and it is very common to reinjure the tendons in the same place, as they generally do not regain their original strength. Orthopaedic surgeons repair damaged rotator cuff tendons by trimming the injured parts, then re-attaching the healthy tendon to the bone. In this study, surgeons will attach a CelGro® patch over the repaired tendon in approximately 30 patients. The CelGro® patch creates a scaffold that promotes regeneration of healthy tendon instead of weaker scar tissue.

For further information about this trial, please visit the Australia and New Zealand Clinical Trials Registry

3. Case series study: treatment of osteochondral defects in the hip using microfracture augmented with CelGro® collagen matrix.

Status: Recruiting patients

Cartilage in the joints, such as the hip, has limited ability to heal itself when injured. If the damaged area is large, it may require surgical treatment to help it heal. Arthroscopic Autologous Matrix Chondrogenesis (AMIC) is an advanced surgical method for repair of hip cartilage. The orthopaedic surgeon makes tiny holes (microfracture) in the area where the cartilage injury is located. This allows stem cells to travel from the bone marrow into the damaged cartilage. The stem cells then mature into new cartilage cells, which work to repair the damaged area. A patch made of collagen is laid over this area, keeping the stem cells in place and providing them with structural support as they make new cartilage. In this study, CelGro®will be used as the collagen patch in 25 patients receiving AMIC treatment.

For further information about this trial, please visit the Australia and New Zealand Clinical Trials Registry

4. Case series study: surgical repair of peripheral nerve injury with CelGro® collagen scaffold.

Status: Recruiting patients

Peripheral nerves allow the brain and spinal cord to communicate with the rest of the body. If a peripheral nerve is cut, torn, or crushed, it can cause paralysis and loss of feeling in the area of the body supplied by that nerve. Severely damaged or completely cut nerves cannot heal themselves and must be surgically repaired. Surgeons reattach the damaged ends with tiny stitches without stretching the damaged nerve. If some of the nerve is missing, this can be difficult. Scaffolds made out of collagen can be wrapped around the cut ends of the nerves, forming a tube that joins both ends without stretching the damaged nerve. This treatment will help the cells in the ends of the nerve to grow towards each other and re-attach properly. In this study, CelGro® will be used to repair damaged peripheral nerves in up to 20 patients.

For further information about this trial, please visit the Australia and New Zealand Clinical Trials Registry

Ortho-ATI®

5. An open label, randomised study of Ortho-ATI® versus surgery for treatment of severe, chronic, resistant lateral epicondylitis.

Status: Recruiting patients

Tennis elbow is a condition where the outer part of the elbow becomes sore and tender. The forearm tendons and muscles become damaged from overuse – doing repetitive arm, elbow, wrist, and hand movements, especially while tightly gripping something. Tendons heal very slowly and it is common to reinjure them in the same place, as they generally do not regain their original strength. Some patients are unable to obtain relief from conservative treatments such as rest, physiotherapy, corticosteroid injection, and may require surgery. Ortho-ATI® treatment may be a less invasive and cost effective treatment for these patients. In this study, 50 patients will be randomly assigned to receive Ortho-ATI® or surgery (25 patients in each treatment group), to determine if there are any differences in long term outcomes with either treatment

For further information about this trial, please visit the Australia and New Zealand Clinical Trials Registry

6. Defining a randomised, controlled study of Ortho-ATI® vs corticosteroid injection for rotator cuff tendinopathy and tear.

Status: Recruiting patients

Corticosteroid injections are a very common treatment for rotator cuff tears that do not respond to simple treatments such as rest, physiotherapy, and oral pain medication. Corticosteriods reduce pain and inflammation providing relief from symptoms, but do not directly assist with repair of the injured tendon. Early intervention with Ortho-ATI® treatment may improve tendon healing and reduce the risk of re-injury. The objective of this study is to assess the safety and effectiveness of Ortho-ATI® compared to corticosteroid injection in the treatment of rotator cuff tendinopathy and tear. The trial is being undertaken in collaboration with DePuy Synthes Products, Inc., part of the Johnson & Johnson Medical Device Companies. In this study, 30 patients will be randomly assigned to receive Ortho-ATI® (20 patients) or corticosteroid injection (10 patients).

For further information about this trial, please visit the Australia and New Zealand Clinical Trials Registry