web analytics

Clinical Trials/Requests for Help

Posted in Looking for Help

LISTING FOR VETERINARIANS/HOSPITALS REQUESTING HELP

If the status of your classified ad has changed or you wish to include an ad in the PCVMA newsletter, please contact Dr. Don Morgan at Donmorgansr@aol.com or 727-397-7387 (PAF/PCVMA Office) or 727-410-7856 (Cell) for the next newsletter.

Also, if you change your e-mail address or practice location, please notify my in
order to continue to receive meeting notices and the news letter.

FDA Pivotal Trial Evaluating the Effect of Intra-articular Allogeneic Umbilical Derived Mesenchymal Stem Cells for the control of clinical signs associated with osteoarthritis in Dogs

Saint Francis Pet Care Centers, with locations in Tarpon Springs and Trinity Florida is currently recruiting dogs with chronic lameness due to osteoarthritis of the stifle, hip, shoulder, or elbow for a clinical trial under the direction of Dr. Michael Amsberry  of The Pet Stem Cell Institute (www.PetStemCells.org) through a study sponsored by Animal Cell Therapies of San Diego California (ACT). 

Study Design:  This is a prospective, randomized, double-blind, placebo-controlled, multi-site, pivotal  clinical field trial conducted at practices within the United States evaluating 320 dogs that  meet the inclusion criteria.  All four major appendicular joints are to be studied (stifles, hips, shoulders, and elbows).  These dogs will receive a single injection of stem cells or LRS in one or two affected joints and evaluated over the course of 12 months post injection.  All candidates receiving the placebo will be invited to receive stem  cell injections at the end of the study. 

Inclusion Criteria:  Any well-tempered–dog over 1 year of age displaying joint pain for at least 3 months, which is not associated with joint instability (ie. Cranial drawer, MPL, hip luxation etc…)   Candidates currently receiving stable dosing of NSAIDs and/or joint supplements may be included.  Dogs with joint deformity, OCD, infectious or immune-mediated arthritis, joint surgery in the last 6 months, previous stem cell treatments or any form of cancer, spinal disease, are excluded.  Dogs intended for breeding, pregnant, or lactating are also excluded.

Compensation:  Study-related medical care is provided by the sponsor, and participating pet owners will be compensated.

 If you would like more information about enrollment in this study, please contact us or see our website  www.PetStemCells.org

Contact:

Heather Birkhimer – Practice Manager

heather@sfvet.us

(727) 937-7600

Blue Pearl Looking for Dogs with Mammary Carcinoma

New Clinical Trial Option for Dogs with Mammary Carcinoma

Do you have any patients that may benefit from this fully funded opportunity?

Evaluation of a New Therapeutic Option for Mammary Carcinoma

A new investigational drug for canine mammary carcinoma is available for your patients. In this pivotal clinical trial, we will examine the safety and efficacy of a novel formulation that has been granted conditional approval by the US FDA for the indication mammary carcinoma. The clinical trial is being conducted in both the EU and US.

Trial Eligibility Criteria

 Female dogs of any age, weight or breed

 Dogs with measurable disease of mammary carcinoma (at least one target lesion with a longest diameter (LD) of ≥ 10 mm) of stage III-V, and in whom, according to the primary care veterinarian and investigator, curative intent surgery cannot be performed or has been declined by the owner

 Criteria regarding stage of disease and concurrent illnesses can be discussed with the investigator

 No prior chemotherapy, radiation therapy, hormonal or biological therapy directed at the target lesion is or has been initiated

 Life expectancy due to the studied disease, in the primary care veterinarian and investigator’s opinions, is greater than 1 month with treatment

 Trial Support and Funding

Dogs will be randomized to receive the new investigational drug or placebo at a 2:1 ratio. Dogs that are randomized to placebo and progress during the 4-cycle treatment period will be offered rescue treatment by the investigator as determined by the protocol.

All diagnostic tests, study drug, rescue medication, and follow-up exams will be paid for by the Study Sponsor.

If you have patients that meet the criteria above, please contact Drs. Curtis Kane or Jen Coyle, or technicians Lexy Julian or Rob Guevara in our Tampa hospital at 813.933.8944.

Blue Pearl Looking for Dogs with Lymphoma - Clinical Treatment Trial

Approximately 25% of dogs with peripheral lymphoma have the T-Cell form. BluePearl is offering a clinical trial to assess the benefit of adding a novel monoclonal antibody treatment to a single-agent CCNU chemotherapy protocol in dogs with T-Cell lymphoma.

This is a randomized, placebo-controlled study. Dogs with peripheral lymphoma will have blood work, radiographs, lymph node biopsy, and flow cytometry performed to confirm the presence of non-indolent T-Cell lymphoma. Those dogs with the T-Cell form will be offered inclusion in the study. Those dogs determined after screening to have B-Cell lymphoma will not be eligible for the study.

Inclusion criteria for screening:

* Dogs older than 1 year of age and at least 10 kg.
* One or more peripheral lymph nodes ≥2 cm diameter
* Owners must be willing to pay for the initial exam, blood work, and
radiographs used to screen potential candidates

Exclusion criteria:

* Prior chemotherapy, immunotherapy or molecular-targeted therapy
* Glucocorticoid therapy for more than 7 days prior to enrollment
* Concurrent uncontrolled medical condition

What do pet owners have to do?

Owners must be willing to pay for their dog’s initial consultation, blood work, urinalysis and thoracic radiographs. Biopsy of the lymph node and flow cytometry to confirm the presence of T-Cell lymphoma will be performed at no charge to the pet owner. Owners must be able to present their dog twice per week for 4 weeks, then every other week for 4 treatments, then monthly for 8 months or until disease progression. Once progressive disease is confirmed, the dog will be removed from the study.

What do pet owners receive if their dog is accepted into the study?

All procedures and treatments required by the study, including chemotherapy, antibody therapy, exams and recheck blood work will be fully funded.

Enrolling your patients in this trial:

If you have patients that meet the criteria above, please contact Drs. Curtis Kane or Jen Coyle, or technicians Emily Kinsler, Lexy Julian, or Brenda Fulcher in our Tampa hospital at 813.933.8944.

Wanted Diabetic Cats

Seeking cats newly diagnosed with uncomplicated diabetes mellitus for participation in a clinical study for a new treatment for diabetes mellitus. For more information, including benefits to you (referral veterinarian) and your client:

http://www.allcatshospital.com/userfiles/2487/pdf/Diabetes_study.pdf