What is heart failure?Heart failure is a condition in which the heart is not able to pump enough blood throughout the body for its normal function. The cause of this can be either functional or structural disorder of the heart. Common causes of heart failure include cardiomyopathy, hypertension, heart valve problems and coronary artery disease. There is no heart failure cure.
Can stem cells help heart failure?
With respect to the heart, stem cells have the ability to not only home into the damaged areas but also to initiate a cascade of biological events which both culminate in healing of the heart muscle. For example, animal studies have demonstrated that stem cell therapy will cause new muscle cells to be formed through stimulation of dormant stem cells that are already inside the heart muscle. In these studies, the administered stem cell also transformed into new heart muscle cells.
At Stem Cell Institute, our investigational stem cell treatments for heart failure involve administration of mesenchymal stem cells harvested from human umbilical cord tissue.
Which kinds of stem cells are used for heart failure and where do they come from?
The adult stem cells used for heart failure at the Stem Cell Institute come from human umbilical cord tissue (allogeneic mesenchymal). These stem cells are expanded at Medistem Panama’s state-of-the-art laboratory.
The mesenchymal stem cells we use are recovered from donated umbilical cords following normal, healthy births. Each mother has her medical history screened and is tested for infectious diseases. Proper consent is received from each family prior to donation.
All umbilical cord-derived stem cells are screened for infectious diseases to International Blood Bank Standards before they are cleared for use in subjects.
Approximately 1 in 10 donated umbilical cords pass our rigorous screening process.
What are the advantages of allogeneic human umbilical cord tissue (HUCT)-derived mesenchymal stem cells?
- They can be used in anyone, since HUCT mesenchymal stem cells are immune system privileged. Human Leukocyte Antigen (HLA) matching is not necessary.
- Allogeneic stem cells can be administered multiple times over the course of days in uniform dosages that contain high cell counts.
- Umbilical cord tissue provides an abundant supply of mesenchymal stem cells.
- No need to collect stem cells through invasive procedures such as liposuction or bone marrow collection
- There is a growing body of evidence showing that HUCT mesenchymal stem cells are more robust than mesenchymal stem cells from other sources such as fat.
The body’s immune system is unable to recognize umbilical cord-derived mesenchmyal stem cells as foreign and therefore they are not rejected. HUCT stem cells have been administered thousands of times at the Stem Cell Institute and there has never been a single instance rejection. Umbilical cord-derived mesenchymal stem cells also proliferate/differentiate more efficiently than “older” cells, such as those found in the fat and therefore, they are considered to be more “potent”.
How are the stem cells administered?
A licensed physician administers the stem cells via intravenous and intramuscular injections (IM) over the course of a few days.
Heart failure investigational stem cell treatment: clinical protocol
Below is an example of a typical 4-day schedule for heart failure. An investigative protocol for heart failure will be submitted soon to the National Committee for review.
- Medical evaluation and blood testing (day 1)
- IV Vitamin C infusion (depending on the subject’s renal function) prior to intravenous injection (IV) of expanded allogeneic (low-passage) mesenchymal stem cells + intramuscular (IM) injections (day 2)
- IV of expanded allogeneic (low-passage) mesenchymal stem cells
- IV Vitamin C infusion (depending on the subject’s renal function) prior to IV of expanded allogeneic (low-passage) mesenchymal stem cells + IM injections (day 4)
- Stemkine supplement for 1 month (only after medical evaluation in Panama)
What is the difference between a stem cell treatment for heart failure and an investigational treatment under clinical protocol for heart failure?
In Panama the term “stem cell treatment” is reserved for stem cell products that have been approved for use by the Panamanian Ministry of Health (PMH). Before PMH approval, use of these products are referred to as “investigational treatment under clinical protocol” to reflect the fact that they are not yet proven and still under investigation.
At present, we are conducting clinical research and administering investigational treatment under clinical protocols that are reviewed and approved by the National Committee for Bioethics in Research Institutional Review Board (IRB) approval. The IRB reviews all investigational clinical protocols and monitors stem cell research involving human subjects.
In the United States, stem cell treatments are regulated by the Food and Drug administration (FDA). In Europe, the European Medicines Agency holds jurisdiction over stem cell treatments.
Currently, no stem cell treatments for heart failure have been proven safe and effective in the United States, European Union or Panama.
Will someone from the Stem Cell Institute be following up with me after I return home?
Periodic follow-up helps us evaluate safety and efficacy. Therefore, our medical staff will be contacting you at regular intervals to see how you are doing (1 month, 3 months, 6 months, and 1 year).
May I speak with someone who has completed a heart failure investigational treatment?
Yes, you may. Once you have been evaluated and approved for participation, your international coordinator will be happy to put you in touch with those who have volunteered to share their experiences in Panama.
You may also take a look at written testimonials, news articles and videos about stem cell therapy for heart failure.
How can I request more information?
You may contact us by telephone 1 (800) 980-STEM (toll-free in US) and 1 (954) 358-3382.
To apply, please complete this Application Form.
Placental Mesenchymal and Cord Blood Stem Cell Therapy for Dilated Cardiomyopathy
Ichim T, Solano F, Brenes R, Glenn E, Chang J, Chan K, Riordan N.
– Reproductive BioMedicine Online 2008; 898-905
Combination of Stem Cell Therapy for Heart Failure
Ichim T, Solano F, Lara F, Paz Rodriguez J, Cristea O, Minev B, Ramos F, Woods E, Murphy M, Alexandrescu D, Patel A, Riordan N.– International Archives of Medicine 2010; 3:5