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Treatment said to save limbs; U.S. scientist hails research, urges more tests
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Jan. 11, 2006
HAVANA — Like many diabetics, Miguel Sobrino suffers from nerve damage that, in turn, inhibits his blood circulation.
A few winters ago, after a small cut on his left foot turned into an ulcer that refused to heal, a condition resulted called “diabetic foot.” With not enough blood reaching his lower extremities, his wound was deprived of the oxygen and nutrients needed to heal.
First, his toes turned black, followed by his foot. Then his ankle began to blacken as gangrene began spreading up his leg. At that point, his doctors scheduled immediate surgery.
“One doctor wanted to amputate to the ankle,” he remembers. “Another to the knee.
"I was in a panic.”
Just days away from surgery, Sobrino sought out one last opinion. “I went to see the physician at my job. And that lucky hunch saved my leg.”
Cutting-edge medical research
It’s even luckier for Sobrino that he doesn’t work just anywhere. The 67-year old gardener tends the sprawling grounds at Havana’s Center for Genetic Engineering and Biotechnology (CIGB), a 754,000 square-foot complex that forms the cutting edge of Cuba’s biotech industry, a priority for the Castro government since 1981.
Marking its 25th anniversary this year, the CIGB has produced an array of health care products for sale on the global pharmaceutical market including a “clot buster” for heart attack victims and a small yellow pill derived from sugarcane that lowers dangerous cholesterol and lipoproteins. In addition, the center claims to have produced the world’s only meningitis B vaccine.
Some U.S. officials have questioned the industry’s real purpose, alleging that it’s a façade for military research to manufacture biological weapons such as like anthrax and bubonic plague. Cuban scientists dismiss the charges, stating that their work is rooted in finding cures for many diseases.
CIGB’s 1,200 researchers are responsible for the lion’s share of Cuban medical discoveries. Mostly due to their efforts, the country has patents pending on some 150 new medicines and technologies that treat a range of diseases — from heart disease and different cancers to AIDS — and is marketing its products worldwide.
Timely advance
At the time of Sobrino’s crisis, a group of scientists had begun testing a new product they named Citoprot-P. Based on a special protein called human epidermal growth factor, they planned to inject the medicine directly into the foot wound in order to stimulate the scar tissue and heal an ulcer incapable of self-repair.
Sobrino was a perfect candidate for their Phase I testing, according to the scientist behind Citoprot-P, Dr. Jorge Berlanga, who also found 28 other volunteers just days away from amputation. “We took the most challenging patients, willing to risk an untried treatment,” he said.
The first tests, conducted at Havana’s National Institute of Angiology and Cardio Vascular Surgery, concluded with a 50 percent success rate, Berlanga said.
In Sobrino’s case, three injections a day for three weeks stopped the gangrene from spreading and reversed most of the damage in his foot, although he lost his toes. The experimental treatment also eradicated the gangrene that had started in his other foot. Three years later, Sobrino has not had a recurrence.
Berlanga said the study also demonstrated that effectiveness was linked to dosage, a discovery that led to a second phase. “We tested 41 critical patients," said Berlanga. "Everyone had between a 90 percent and 100 percent probability of amputation. With the higher dose, we successfully regenerated the scar tissue in 85 percent of the cases.”
The drug is now in Phase III clinical trials and is being tested on some 100 patients island-wide.
Dr. Pedro Lopez, CIGB’s director of regulation and clinical study, is convinced Berlanga has made a significant discovery. “Even if the average drops to 50 percent success, we’ll still be saving countless lives,” said Lopez, who said he considers himself a cautious man. ....
Mathaba News Network are reporting: Cuban Expands Medication to Treat Diabetic Foot Ulcers
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Heberprot-P, a medication produced by Cuban biotechnology, reduces the number of surgical operations, cicatrization time, possible complications like gangrene and infections, and avoids high costs derived from long-time hospitalization; it also improves quality of life and the functional recovery of patients.
Havana, May 31 (acn) Cuba will soon distribute a medication, only one of its kind in the world, to treat diabetic foot ulcers in all Angilology services in the country. In statements to the press in Havana, the director of the Genetic Engineering and Biotechnology Center (CIGB) Doctor Luis Herrera underscored the advantages of the medication produced by his entity, known as Heberprop-P, which has been administered to more than 250 Cuban patients, with successful results and full response by 87 of the cases.
Doctor Ernesto Lopez, head of the CIGB commercial division, explained that Heberprot-P is and injectable formula that steps up the cicatrization of deep and complex ulcers, thus reducing the number of amputations.
Doctor Lopez said that the medication has been registered in Cuba and included in the basic medications program; it has been patented in South Africa, Australia and Singapore. The Cuban medication is also expected to be patented in Japan, the United States and in Europe.
There are 350, 000 diabetic patients in Cuba, 12,000 of whom may be suffering from diabetic foot ulcers, while the number of amputations could reach up to 1,800, the doctor explained.
With that in mind, said the specialist, Cuba is creating all conditions and training personnel to administer Heberprot-P throughout the country including primary medical attention. Doctor Perez added that the medication will be available to all patients suffering from diabetic food ulcers.
Heberprot-P, a medication produced by Cuban biotechnology, reduces the number of surgical operations, cicatrization time, possible complications like gangrene and infections, and avoids high costs derived from long-time hospitalization; it also improves quality of life and the functional recovery of patients.
Doctor Jorge Berlanga, also from the CIGB, explained that 85 percent of amputations can be prevented, while 70 percent of those surgeries are applied on patients suffering from diabetes, a disease affecting some 194 million people around the world.
Press Release: European Union to Test Cuban Drug Heberprot-P
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A Cuban drug used in the treatment of diabetic foot ulcers is due to be tested by the European Union, a specialist announced in Havana.
Ernesto Lopez, director of the commercial department at the Genetic Engineering and Biotechnology Center, said the pharmaceutical Heberprot-P will be tested in some 700 patients, in a hundred hospitals across the European Union. The clinical test is based on previous assays carried out at healthcare centers in Spain.
According to experts, this will be the most significant diabetic foot research study in the world, from the clinical and scientific perspectives, with great expectations about its results.
The Cuban pharmaceutical, known as Heberprot-P, has become a leading product for the Genetic Engineering and Biotechnology Center, in terms of sales which are expected to translate into more than 100 million dollars this year.
The Havana-based scientific institution developed the one-of-its-kind medication in joint work with the Institute of Angelology and Vascular Surgery.
Heberprot-P has been patented in over 40 countries with 17 sanitary registrations allowing its use by health ministries of other countries.
In Cuba the treatment of diabetic foot ulcers is being administered in 192 healthcare centers and 43 hospitals with major efforts focusing on primary health attention
Heberprot-p: a novel product for treating advanced diabetic foot ulcer.
Berlanga J, Fernández JI, López E, López PA, Del Río A, Valenzuela C, Baldomero J, Muzio V, Raíces M, Silva R, Acevedo-Castro BE, Herrera L. MEDICC Rev. 2013 Jan;15(1):11-5.
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Diabetic foot ulcer is a principal diabetic complication. It has been shown that diabetic patients have decreased growth factor concentrations in their tissues, particularly epidermal growth factor. Growth factor shortage impairs wound healing, which leads to chronic nonhealing wounds and sometimes eventual amputation. Ischemic diabetic foot ulcer is the most difficult to treat and confers the highest amputation risk. Injecting epidermal growth factor deep into the wound bottom and contours encourages a more effective pharmacodynamic response in terms of granulation tissue growth and wound closure. Epidermal growth factor injected into the ulcer matrix may also result in association with extracellular matrix proteins, thus enhancing cell proliferation and migration. Heberprot-P is an innovative Cuban product containing recombinant human epidermal growth factor for peri- and intra-lesional infiltration; evidence reveals it accelerates healing of deep and complex ulcers, both ischemic and neuropathic, and reduces diabetes-related amputations. Clinical trials of Heberprot-P in patients with diabetic foot ulcers have shown that repeated local infiltration of this product can enhance healing of chronic wounds safely and efficaciously. As a result, Heberprot-P was registered in Cuba in 2006, and in 2007 was included in the National Basic Medications List and approved for marketing. It has been registered in 15 other countries, enabling treatment of more than 100,000 patients. Heberprot-P is a unique therapy for the most complicated and recalcitrant chronic wounds usually associated with high amputation risk. Local injection in complex diabetic wounds has demonstrated a favorable risk-benefit ratio by speeding healing, reducing recurrences and attenuating amputation risk. Further testing and deployment worldwide of Heberprot-P would provide an opportunity to assess the product's potential to address an important unmet medical need.
Cubans developing therapy for diabetic ulcers
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