Stem Cell FDA Study
Seeking Patients to enroll in an FDA stem cell study
Dr. Adams is seeking dogs with osteoarthritis to enroll in a double blind, FDA study. All patients enrolled in the study will receive intra-articular injection(s) of stem cells in 1-2 arthritic joints. Joints that will be treated include knees, hips, shoulders and elbows. The two joints treated can be any combination of the listed joints.
This is a double blind study; half of the qualified patients will receive stem cells at the beginning of the study, and half will receive a benign placebo injection. At the conclusion of the 6- month study those patients who did not received stem cells will have the option of having the arthritic joint(s) injected with stem cells. 100 % of the costs for the study will be covered for the enrolled patients, including the diagnostics and stem cells. If a pet does not fit all criteria for enrollment in the study the cost of examination is the responsibility of the owner, see below. *If you are interested in seeing if your pet is eligible for enrollment in the study review the criteria listed below.
- Age 9 months or older
- Weight 5.5 pounds or larger
- Male or female, neutered or intact (no pregnant or breeding females)
- Good general health – stable hypothyroid patients are eligible
- 1-2 arthritis joints with changes confirmed on x-ray
- No additional orthopedic, soft tissue or neurologic problems that affect mobility
- Patients who have had PREVIOUS STEM CELL TREATMENT do not qualify
- No known cancer
- Normal blood work, fecal and urinalysis
- No joint surgery within the previous 90 days – previous joint surgery is OK
- No other type of surgery or anesthesia for 30 days prior to enrollment
- No surgery scheduled during the 6 months of the study
- No acupuncture or chiropractic care within 20 days, none during the study
- No laser for 30 days prior to or during study
- No injectable glucosamine (Adequan) or hyaluronic acid 30 days prior to or during study
- Oral pain meds and glucosamine OK if at least 30 days duration, medications must remain stable during the duration of the study
- Stable diet, at least 60 days for a joint diet, 2 weeks for a non-joint diet, no change during the study
Aggressive, uncooperative animals will not be enrolled
Owners must be willing to meet all requirements of the study for the duration of the 6 months, including all necessary exams and communications.
If your pet fits the eligibility requirements listed above schedule an appointment
for screening with Dr. Adams at (303) 710- 7689.
An initial examination will be done to confirm your pet meets the study requirements; if current x-rays are needed they will be taken and reviewed that day, and required laboratory work with be submitted. If all diagnostics meet the requirements your pet will be officially enrolled, stem cells will be ordered and a time scheduled for sedation and injection of the affected joints. All costs for examinations and diagnostics are covered for patients who qualify and are enrolled.
All patients must be healthy and orthopedically stable enough with their current supplements, medications and level of exercise not to need medical intervention during the 6 months, even if they receive a placebo injection. Any patients who needs medical intervention during the study period are encouraged to be treated by the doctor or hospital participating in the study, but any appropriate treatment should be sought. Any injuries or illnesses must be reported as “adverse events” even if unrelated to the stem cell treatment. These patients may not be included in the final data for the study but will still be required to complete all exams and phone calls required for the duration of the study.
*If your pet does not meet the requirements for the study the cost of the examination will be the responsibility of the owner. Other options for treatment can be discussed during the exam, including autologous stem cell treatment, animal chiropractic, acupuncture, supplements and rehabilitation options.