Stem cells shown to restore erection capability in men with erectile dysfunction

By ScienceDaily

New clinical trial results show that stem cells can restore sufficient erectile function to allow previously impotent men to have spontaneous intercourse. This is the first time stem cell therapy has produced patients who have recovered sufficient erectile function to enable intercourse. This is an early trial, which was primarily addressing safety and dosage (a Phase 1 trial), so the results need to be interpreted accordingly.

In recent years several groups have worked to develop stem cell therapy as a cure for erectile dysfunction, but until now the improvements have not been sufficient to allow affected men to achieve full sexual intercourse. Results presented at the European Association of Urology conference in London show that 8 out of 21 have successfully regained sexual function.

Lead researcher, Dr Martha Haahr (Odense University Hospital) said “What we have done establishes that this technique can lead to men recovering a spontaneous erection — in other words, without the use of other medicines, injections, or implants. We are now beginning a larger Phase 2 trial to better evaluate its effectiveness and confirm its safety.”

Erectile dysfunction affects nearly half of men between the ages of 40 and 70 to some degree. There are several possible causes, including surgery (e.g. prostate surgery), high blood pressure, diabetes, cardiovascular disease and psychological problems. Current remedies, which include medications such as PDE5 inhibitors (such as Viagra and Cialis), injections, or penile implants; all have some disadvantages, so scientists have been searching to find a way which restores natural sexual function. The present work focuses on patients with physical damage, caused by surgery (radical prostatectomy) for prostate cancer.

The research group, from Odense in Denmark, used stem cells taken from abdominal fat cells via liposuction (under a general anaesthetic): none of the 21 men reported significant side effects over the trial period, or in the following year. After isolating the stem cells, they were injected into the corpus cavernosum area of the penis. The patients were able to be discharged the same day.

Within 6 months of the treatment, 8 out of the 21 patients reported that they had recovered sufficient erectile function to achieve penetrative) sexual activity. This improvement has been maintained for a year, indicating that this treatment may confer long-term benefits. Only those men who were continent were reported to have recovered sexual function (incontinence is also one of the risks of radical prostatectomy prostate surgery).

Contact your doctor or seek emergency medical interest in case your erection is painful or lasts longer than four hours. A prolonged erection (priapism) can harm the penis.
The dose may be accelerated to twenty mg or reduced to 5 mg, primarily based on character efficacy and tolerability. The maximum endorsed dosing of Cialis generic is as soon as in keeping with day in most sufferers.
Cialis can help gain an erection whilst sexual stimulation happens. An erection will no longer occur just through taking a pill. follow your physician’s instructions.
CIALIS to be used as wanted was shown to enhance erectile characteristic compared to placebo up to 36 hours following dosing. therefore, when advising sufferers on best use of CIALIS, this need to be taken into consideration.

Using the generally-accepted IIEF questionnaire to measure erectile function, the whole group of 21 patients reported that their score had increased from 6 before the stem cell transplantation surgery, to 12 after 6 months. However, in the group of men who recovered sexual function, the IIEF score increased from 7 to 14 (the average in men with ‘normal’ sexual function is around 25). This is enough to enable some of the continent men to have a spontaneous erection sufficient for penetrative sex, others achieved this with the help of medication.

Dr Martha Haahr said: “We are the first to use a man’s own fat stem cells as a treatment for erectile dysfunction in a clinical trial. The technique has been trialed in animal work, but this is the first time stem cell therapy has allowed patients to recover sufficient erectile function to enable intercourse.

We are pleased with the preliminary outcomes, especially as these men had previously seen no effect from traditional medical treatment and continue to have good erectile function after 12 months follow-up, indicating that this might be a long-term solution. This suggests the possibility of therapeutic options for patients suffering from erectile dysfunction from other causes. But we need to remember that this is a small trial, with no control group. We’re still some time away from a clinically available solution.”

Commenting Professor Jens S√łnksen (Herlev, Denmark), member of the EAU Scientific Congress Committee, said “This is interesting and novel research looking into the future. The study by Haahr and co-workers is preliminary and more research is needed on the topic. But there is no doubt that stem cell therapy will become an important tool in the treatment of erectile dysfunction. ”


Sildenafil May Help Heal Scleroderma Ulcers


Sildenafil (Viagra) provided some benefits for digital ulcer healing in patients with systemic sclerosis (SSc), although the primary endpoint of a placebo-controlled trial was not met, French researchers reported.

Compared with patients receiving placebo, the hazard ratio for healing of digital ulcers among patients randomized to sildenafil, 20 mg three times daily for 12 weeks, was 1.33 (95% CI 0.88-2, P=0.18) in an unadjusted analysis and 1.27 (95% CI 0.85-1.89, P=0.25) in an analysis adjusted for the number of ulcers present at baseline, according to Eric Hachulla, MD, PhD, of the Scleroderma National Center, University de Lille, and colleagues.

Nonetheless, the mean number of digital ulcers per patient was significantly lower in the sildenafil group at week 8 (ratio 0.69, 95% CI 0.47-0.99, P=0.04) and week 12 (ratio 0.57, 95% CI 0.37-0.88, P=0.01), the researchers reported online in Annals of the Rheumatic Diseases.

The failure to meet the primary endpoint could have resulted from an unexpectedly high placebo response, they explained.

“In cross-sectional studies involving patients with SSc, the frequency of ischemic digital ulcers was 12% to 16%, with a major impact on hand function and quality of life,” they wrote.

But minimal success has been seen thus far with treatment. One drug that has been evaluated is bosentan (Tracleer), which was beneficial in decreasing the occurrence of new ulcers but lacked efficacy in increasing the time to healing.

Sildenafil is a phosphodiesterase type 5 (PDE-5) inhibitor that blocks cyclic guanosine monophosphate breakdown, which lowers intracellular calcium and leads to smooth muscle relaxation.

“Because of their vasodilating, angiogenic, and decreased platelet aggregation properties, PDE-5 inhibitors may have a potentially beneficial effect on digital ulcer healing,” stated Hachulla and colleagues.

And small studies of both sildenafil and tadalafil (Cialis) suggested a potential benefit, so the investigators undertook a prospective study in 25 centers that included 83 patients with 192 digital ulcers at entry.

Patients’ mean age was 49, and more than three-quarters were women. Mean time since the onset of symptoms other than Raynaud’s phenomenon was just under 7 years.

The mean number of ulcers per patient was 2.5 in the placebo group and 2.1 in the sildenafil group, and almost all patients had at least one digital ulcer 2 mm in diameter or greater.

Pain intensity was reported as being 59 on a 100-mm scale the previous week, the Health Assessment Questionnaire disability index was 1, and hand disability was scored as 30 out of a possible 90 on the Cochin hand function scale.

Secondary outcomes also favored sildenafil, although statistical significance again was not met. For example, in 70.3% of patients in the sildenafil group, all baseline ulcers had healed by week 12, compared with 60.5% of the placebo group (OR 1.50, 95% CI 0.52-4.37, P=0.45).

In addition, 67.6% of sildenafil patients and 48.7% of placebo patients were free of ulcers at week 12 (OR 2.20, 95% CI 0.86-5.65, P=0.10).

Moreover, new digital ulcers appeared between weeks 4 and 12 in 21.6% of patients receiving sildenafil but in 39.5% of those given placebo (OR 0.42, 95% CI 0.15-1.17, P=0.10).

Significant differences between the active treatment and placebo also were not found in the subgroup of patients who were receiving concomitant bosentan after adjustment for disease severity.

Four patients experienced complications of the digital ulcers. One patient in the sildenafil group developed a skin infection and gangrene, while three placebo patients had skin infections. Five patients in the sildenafil group discontinued treatment for adverse events such as syncope and rash, as did three in the placebo group because of events such as leg edema and headache.

In discussing possible reasons for the limited efficacy seen in the study, Hachulla and colleagues noted that 66% of ulcers that were present at the time of study entry had healed by week 12 in the placebo group, which was more than twice what they had expected based on an earlier study.

“Since all participating centers were highly experienced in the treatment of SSc and digital ulcers, the local digital ulcer treatment provided was certainly more effective than the treatment given 10 years ago,” they stated.

Furthermore, more than half of the placebo patients were on vasodilating calcium channel blockers, which were found in a retrospective study to decrease the risk of these ulcers in SSc.

A limitation of the study was the possibility that too low a dosage of sildenafil was used. In pulmonary arterial hypertension, the drug has been given in dosages as high as 80 mg three times per day.