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Seeking Boulder Area Patients For New Peptide-Based Arthritis Clinical Trial
An Investigational Research Study On The Effects of "AOD 9604" Peptide With Hyaluronic Acid on:  
  • Reducing Pain As Measured On Womac Scale 
  • Improving Joint Mobility (Knee)
  •  Regenerating Cartilage
A Next Generation Approach:


Elizabeth F. Yurth MD

ABAARM, FAARM, FAARFM, CPS
* Program Director
* Co-Founder & Medical Director- Boulder Longevity Institute
Call Now For Your Free Phone Consultation
Speak with one of our friendly in-office staff. 
Seeking Boulder Area Patients For New Peptide-Based Arthritis Clinical Trial
Initial clinical studies report the combination of "AOD 9604" peptide with hyaluronic acid may result in:  
  • Reduced Pain As Measured On Womac Scale
  • Increased Mobility
  •  Cartilage Regeneration
A Next Generation Approach:
"The most promising arthritis study I've seen in 20+ years..."


Elizabeth F. Yurth MD

ABAARM, FAARM, FAARFM
* Program Director
* Co-Founder & Medical Director- Boulder Longevity Institute
Call Now For A Free Consultation With One Of Our Friendly Staff
Watch The Study Orientation Video 
About The Clinical Trial
Study Overview
AOD9604 is a peptide (small-chain amino acid) that was originally brought to market as an anti-obesity drug (AOD), but more recently AOD9604, which has GRAS Status (Generally Recognized As Safe for use in foods), has come to the attention of researchers and clinicians investigation of its potential role in the regeneration of joint cartilage. This resurgence in interest in AOD has been driven in large part by a recent animal study which analyzed the impact of AOD9604 plus Hyaluronic Acid, a naturally occurring human compound found in joints on damaged rabbit cartilage.

Interestingly, a rabbit knee has very similar cartilage and joint composition to that of the human knee. In small scale rabbit model studies of osteoarthritis, AOD9604 + Hyaluronic Acid injections have been shown to regenerate damaged rabbit cartilage. The applicability of these results, including safety and efficacy to humans, remains to be established, and is the subject of this clinical study. 

Boulder Longevity Institute’s is one of the top Regenerative Peptide Therapy Clinics in the nation with an expert staff in Functional and Regenerative Medicine as well as orthopedics.

Technical Background
The exact mechanism of action creating the positive outcomes from the AOD+HA injections is unknown. It is speculated that AOD9604 is similar to Growth Hormone (GH) and balances the catabolic and anabolic mechanisms seen in osteoarthritis potentially by supporting increased differentiation of bone and cartilage cells. This study will examine, among other things, the effectiveness of AOD9604 in this indication, as well as its safety and effect on IGF-1 levels, which is a concern with growth hormone.


Study Details
This is a 5-month study which begins with an On-Boarding Appointment and first injection, followed by 3 more weekly injections (so 4 injections in the first month), and then 4 more monthly injections, for a total of 8 injections.

Before each injection, study-subjects will be required to fill out a brief questionnaire regarding the status of their knee pain using the WOMAC (The Western Ontario and McMaster Universities) Osteoarthritis Index. In addition, the study subject will be asked to review and sign an "Informed Consent" which outlines the known risks associated with the product and provides their consent to participating in the clinical trial. 

The first injection appointment will last 40-minutes. Subsequent appointments will last 15 minutes (for one knee) or 25-minutes (for two knees). Appointments will take place at Boulder Longevity Institute (BLI), 250 Arapahoe Avenue, Suite 102, Boulder, CO 80302.

Do I Qualify For The Trial?
Participants must be suffering from chronic knee pain and preferably have been diagnosed with osteoarthritis in the knee. Participants cannot have had any surgery, injection, or other invasive procedure done on the knee within the last six-weeks. This study is not open to candidates with acute knee injuries, without first undergoing an orthopedic evaluation thru Boulder Center For Orthopedics with Dr. Elizabeth Yurth.

Cost of the Study
This study is not covered by insurance.  However, because of discounts provided by the compounding pharmacy that is supporting the study, participants receive a significant discount off the cost of the injection protocol. Payment is due prior to study participation. Please give us a call for specific pricing.


Frequently Asked Questions

Study Background:

Why is this study being conducted?
Results from both rabbit-model osteoarthritis research and anecdotally from off-label use of AOD9604 plus Hyaluronic Acid have suggested investigative potential for the research of this combination in treating osteoarthritic knee pain in humans.

Who is sponsoring the study?
Tailor Made Compounding Pharmacy, a leader in peptide research, development and manufacturing along with global medical orthopedic device innovator, Arthrex, are sponsoring this study and providing the discounted peptides for study use.

Who is conducting the study?
A handful of clinics across the country, that have expertise in the use of peptides and/or orthopedic treatment of joint osteoarthritis have been selected to conduct the study.

Who is the lead researcher on the study?
William A. Seeds, MD, Chairman & Medical Director of the International Peptide Society and Faculty Member of the American Academy of Anti-Aging Medicine is the lead researcher for the study.

How many people are involved in the study?
Nationwide, over 120 people have participated in the study since its inception in February of 2018. Boulder Longevity Institute began seeing participants in August, 2018 and currently has just a handful of participants.

How many other clinics are involved in the study?
As of August, 2018 this US-based study has 6 specialty clinics participating.

How long has the study been going on? 
The study began in earnest in February of 2018.

How long has BLI been doing the study?
BLI began seeing study participants in August, 2018.

How long will the study continue to run for?
Boulder Longevity Institute should be able to register participants in this study for approximately 4-6 months, although this will be dependent on whether the study fills from other institutions involved so interested people would be advised to register sooner rather than later.

What is AOD 9604?
AOD9604 is a GH fragment which comprises the last 16 amino acids of the larger growth hormone molecule. Although originally studied for fat loss, further studies are investigating its use in regenerative medicine. In combination with hyaluronic acid (HA), it is now being researched in the indication of regeneration of hyaline cartilage and in the treatment of osteoarthritis. 

The combination appears to act, in preliminary research to enhance the differentiation of adipose mesenchymal stem cells into bone, promote proteoglycan and collagen production in chondrocytes, and promote differentiation of myoblasts into C2C12 cells; all of which are involved in bone, cartilage, and muscle repair, which is the subject of this research. These studies are designed to determine if it has stronger therapeutic benefits compared to Bone Marrow Aspirate Concentrate (BMAC) and Platelet Rich Plasma (PRP) therapy, which are also being investigated as candidates for osteoarthritis medications.

What is hyaluronic acid?
Hyaluronic acid is a substance that is naturally present in the human body. It is found in the highest concentrations of fluids in the eyes and joints. The hyaluronic acid that is used as medicine is extracted from rooster combs or made by bacteria in the laboratory. However, in joints affected by arthritis, hyaluronic acid levels are extremely low, causing the synovial fluid to become less viscous and the cartilage less cushiony. For years, orthopedists have injected hyaluronic acid directly into the synovial spaces of arthritic joints for relief of pain and inflammation.

Why are they being combined for this study?
In the NCBI study published in the Annals of Clinical & Laboratory Science, intra-articular AOD9604 injections using ultrasound guidance enhanced cartilage regeneration, and combined AOD9604 and HA injections were more effective than HA or AOD9604 injections alone in the collagenase-induced knee OA rabbit model. Therefore, the human trials are combining both to investigate whether the addition of AOD9604 improves efficacy.

Why are we doing something based off a rabbit study? How is this comparable to humans?
Interestingly, a rabbit knee has very similar cartilage and joint composition to that of the human knee. In small scale rabbit model studies of osteoarthritis, AOD9604 + Hyaluronic Acid injections have been shown to regenerate damaged rabbit cartilage. The authors of the rabbit study stated the following regarding the conclusion to be drawn from the study. "It is not advisable to generalize our results for the OA in a rabbit model because of the small sample size of this study. Further studies with larger sample sizes and longer follow-ups are necessary to establish the validity of our results. Moreover, the different effects caused by varying intra-articular dosages, formulations, and injections intervals need to be assessed." Nevertheless, this clinical study is needed to determine if the activity of AOD9604 observed in rabbits will replicate in humans, and provide a picture of the effectiveness and safety of the combination in humans.  

Is the only research available on rabbits?
At present the only research specific to the use of AOD9604 related to joint cartilage regeneration is this rabbit study: Effect of Intra-articular Injection of AOD9604 with or without Hyaluronic Acid in Rabbit Osteoarthritis Model, which can be found here. We of course cannot draw conclusions about the activity (safety and effectiveness) in humans until the completion of clinical trials of use in humans, which is the purpose of this study. 

Is AOD9604 FDA Approved?
AOD9604 has GRAS status. Generally recognized as safe (GRAS) is a designation under the American Food, Drug and Cosmetic Act, implemented by FDA regulations that a chemical or substance added to food is considered safe by experts. It is not approved by the FDA for use as a drug for any indication at the present time. 

Is Hyaluronic Acid FDA Approved?
Certain products containing hyaluronic acid as an ingredient have been approved by the FDA for treating osteoarthritis of the knee. The hyaluronic acid used in this study is not a product approved by the FDA. 

Has AOD9604 ever been used in humans before?
AOD9604 was originally developed in Australia as an anti-Obesity drug (AOD). There it underwent human trials in over a half dozen studies. While these trials did not prove any significant efficacy for weight loss, they did not show safety signals. The safety and effectiveness of the combination of AOD9604 and hyaluronic acid used in this study remains to be determined. 



Resources:

Where can I find more information about AOD 9604? What related studies or research can I reference to read more about this?
Almost all of the information on the internet about AOD9604 is related to its use as an anti-obesity drug. Two papers relevant to this study are:


Can I speak to someone else who has participated in the study so I can see what their experience/outcome was?
Unfortunately, privacy laws do not allow us to share study-participant information.



Who Qualifies for the Study – Who Doesn’t:

Who qualifies for the study?
Any adult age 25 or greater that has suffered from chronic knee pain for over 6-months is a potential candidate. Optimally, candidates have been formally diagnosed with osteoarthritis of the knee, but this is not required.

You do not qualify for the study if:
Your knee pain is the result of an acute injury occurring within the last 6-months
Your knee pain is related to instability or “catching” of the knee
You have had surgery, an injection, or any other invasive procedure on the knee within the last 6-weeks.

I don't have pain but was told I have arthritis, do I still qualify?
The basis if this study is the WOMAC (Western Ontario and McMaster Universities) Osteoarthritis Index, whose primary metric is changes in knee pain. That said, the goal of the study is to investigate the product in the regeneration of cartilage, in the indication of arthritis. 

I just had surgery; can I still participate in the study?
If you have had knee surgery within the last 6-weeks you do not qualify. If your surgery was more than 6-weeks ago you can participate in the study.

I was just sick; do I need to wait to start participation?
Please call BLI to discuss your specific situation. Most mild illnesses are not an issue but more severe problems might need to wait.

I'm going on vacation for a couple weeks next month, should I wait to start participation?
The study protocol requires 4 consecutive weekly shots, followed by 4 consecutive monthly shots. If travel will impact following this protocol, you should consider delaying the start of your participation. There is some flexibility on the monthly shot timing (+/- a few days). The weekly shots should occur at the 7-day intervals +/- a day.

I just had surgery on something else, will participation in the study help that heal?
This study involves an intra-articular (inside the joint) knee injection and there is no current information indicating the AOD works systemically to promote regeneration or healing elsewhere. 


Study Logistics:

How does the study work? How long will it take? What do I need to do? Where do I need to go?
Initial visit: During this visit you will fill out your baseline questionnaire, get information about the injection procedure, AOD9604+HA, the study protocol, informed consent, and be able to ask any additional questions. You will also get your first injection. This appointment will take approximately 40-minutes.

Three weekly follow-up injection visits: At these visits you will fill-out follow-up questionnaires, receive your weekly injection, and update the Peptide Consultant about your status and progress. These appointments will take between 15 (one knee) and 25 (two knees) minutes.

Four monthly follow-up injection visits: At these visits you will fill-out follow-up questionnaires, receive your monthly injection, and update the Peptide Consultant about your status and progress. These appointments will take between 15-minutes (one knee) and 25-minutes (two knees).

For each injection you need to wear or bring clothing that allows for easy unrestricted access to your knee(s) for the injection. 
All appointments/injections take place at Boulder Longevity institute (BLI) 250 Arapahoe Avenue, Suite 102, Boulder, CO 80302. In total the study involves eight (8) injections taking place over a period of five (5) months.

Where will I get the injection?
The injection is into the joint entering on the outside of your knee just under the kneecap. The medication, however, will disperse throughout the entire joint much like filling a balloon.

Is the injection painful?
We use a numbing agent at the site of the injection and there are minimal nerve-endings in the joint itself so most clients do not experience pain. Generally, the shot is described as being “uncomfortable” as the needle is being inserted, but not painful. However, some clients that have existing structural issues in the knee do experience more discomfort and in some instances brief pain as a path into the knee joint is being navigated.

How many needles/injections per visit? Are the AOD peptide and the Hyaluronic Acid (HA) in the same syringe?
The AOD and the HA are drawn-up in the same syringe so each visit requires only one injection per knee being treated.

After the study protocol is completed, can I continue to receive treatment?
Yes, after completion of the study you can continue to receive injections by signing up for an appropriate program. Study clients that are not already part of the Program will receive a discount on their Regenerative Peptide Assessment. Please Note: The provider of the AOD9604+HA is providing it at a significant discount for the study. That discounted pricing will no longer be available after you have completed the study.

How will the study results be measured?  
Study results are being measured by the change in participants WOMAC (Western Ontario and McMaster Universities) Osteoarthritis Index score. 


Potential Risks, Side Effects, and Other Options:

What potential side effects are there from the injection ?
Risks of the knee injection include increased pain, infection, allergic reactions, nerve injury, and, rarely, pseudosepsis, which is a severe inflammatory reaction that may require aspiration, steroids and even surgical management.

Is there any downtime? Will I not be able to do certain activities?
Some clients experience tenderness or discomfort after the injection. Anticipate waiting 24-48 hours after the injection to resume your full range of normal activity.

Boulder Longevity Institute is one of a very few clinics with a Medical Director that has a dual-fellowship in Regenerative Medicine. As such, we are well qualified to unravel the confusing tangle of Regenerative Treatment claims. We are happy to answer questions about AOD+HA specifically.

I was considering knee surgery. Why should I do this instead?
Surgery is sometimes the obvious solution for severe cases and we cannot make any claims for the regenerative treatments at this time. We hope that this study will provide important information on the relative risks and benefits of the various treatment options available for patients. 

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