Current Clinical Trials at Synergy Integrative Specialty Veterinary Clinic (SIVC)
The following clinical trial(s) are currently accepting new patients at SIVC:
A Canine Cranial Cruciate Injury Clinical Trial offered in Eastern N.C.
Partial Cranial Cruciate Ligament Tears Treated with an Allogenic Amnionic Allograft Administered by Peri-Articular Acupuncture Injection compared to Intra-articular Injection Methods in Dogs
Date: September 2017 – February 2018
A multi center, randomized, masked, placebo-controlled study to demonstrate the effectiveness of an amniotic regenerative medicine treatment in dogs diagnosed with a < 50% Cranial Cruciate Ligament (CCL) tear. Diagnosis of the CCL tear is confirmed by use of a needle arthroscope. This will be a 2-phase study, with the goal in Phase 1 to first evaluate the effectiveness of an amniotic product using the standard intra-articular injection method to treat CCL tear. After the success of Phase 1 study, the Phase 2 study will aim to demonstrate that the less invasive acupuncture (Aqua-AP) or periarticular delivery technique can produce the treatment outcome at least as good as the standard intra-articular injection method.
An amniotic allograft is a biologic product that can be given by both a standard Intra-articular injection and peri-articular acupuncture delivery to successfully heal a partial damaged CCL in the dog.
Clinical Significance and Background
- Clinical Problem: The cranial cruciate ligament (CCL) is necessary to stabilize the stifle joint in dogs. The rupture of this ligament is one of the most common causes of hind limb lameness noted in small animal practice.
- Current Treatment: Surgical intervention is most often recommended to correct and stabilize CCL and return the patient back to function. However, no specific surgical procedure has been established as the gold standard for this condition.
- Rationale of proposed solution: The expensive cost of surgery, invasive nature of surgery, and post operative complications often leave a client looking for a less expensive, less invasive or alternative means to treat their dog and ease the pain. Traditional Chinese Veterinary Medicine (TCVM) has long been considered to be a very safe and effective method to improve physical function, quality of life, range of motion, and control pain in stifle joint injuries. Regenerative medicine using mesenchymal stem cells (MSC) and growth factors from platelet rich plasma (PRP) also has been proved being very effective in treating stifle joint injuries over the past 15 years in small animal medicine (1-3). MSC and progenitor cells have the potential to differentiate into multiple cell lineages including bone, cartilage, and connective tissue such as ligaments. The use of a surgical harvest of adipose and/or bone marrow stem cells has been very promising in healing numerous orthopedic conditions. Still, many veterinary patients are physically compromised, aged, and unable to endure the invasive harvest of stem cells and the anesthesia needed for these cells to be injected back into the patient. Ultimately, this joint study seeks to demonstrate that an allogeneic amniotic regenerative product can be successful in healing CCL tear in dogs when administered to the patient at the site of injury without the need for any future anesthesia or any surgical methods by use of TCVM acupuncture injection techniques.
- Dogs are between 1-13 yrs of age and weigh 30-100 pounds of any breed or gender.
- Dogs referred for the reason of a single rear limb lameness and no other concurrent medical conditions noted within 2 months of clinical trial enrollment.
- Dogs whose owners agree and are open to a less invasive and non-surgical approach to heal a damaged CCL.
- Dogs who have a definitive diagnosis of <50% CCL tear when confirmed under anesthesia with the use of a needle arthroscope.
- Dogs with multi limb lameness and ongoing underlying concurrent metabolic disease.
- Dogs with a >50% CCL tear will need a surgical referral and are NOT a candidate for this trial.
- Dogs currently on immunosuppressive doses of corticosteroids.
- Dogs whose owners are not interested in an alternative CCL therapy to surgical management by TPLO/TTA.
- Dogs whose owners are not willing to allow 2-3 anesthetic procedures using needle arthroscopy to diagnose joint pathology or follow up visits as outlined in the study protocol. Dogs and owners are unable to return for reevaluations at 60, 90, 120 days.
Required 60, 90, 120 days post treatment.
- (Cost: grant money may be provided as funds are made available). Contact / For More Information: SIVC at (252) 631-5033 ask for Dr. Gerardi DVM CVA CVFT MS-TCVM