Cubans developing therapy for diabetic ulcers

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.

In the first two trials, patients taking Citoprot-P experienced few adverse reactions. Some patients ran low-grade fevers and one patient dropped out, said Lopez. “Up to now, the product appears to be safe.”

Citroprot-P also seems to work slightly better in men than women, something being looked at in the next study.

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