Therapeutic vascular angiogenesis for intractable macroangiopathy-related digital ulcer in patients with systemic sclerosis: a pilot study
| Autor: | Masaaki Miyamoto, Sonoko Kirinoki-Ichikawa, Tomohito Hada, Ikuyo Takagi, Kyoichi Mizuno, Gen Takagi, Shuhei Tara, Yoshiaki Kubota |
|---|---|
| Rok vydání: | 2014 |
| Předmět: |
Male
medicine.medical_specialty Endpoint Determination medicine.medical_treatment Ischemia Neovascularization Physiologic Pilot Projects Scintigraphy Systemic scleroderma Gastroenterology Fingers Peripheral Arterial Disease Rheumatology Internal medicine medicine Humans Pharmacology (medical) Vascular Diseases Adverse effect Ulcer Aged Bone Marrow Transplantation Pain Measurement Arteriosclerosis obliterans Scleroderma Systemic medicine.diagnostic_test business.industry Arteriosclerosis Obliterans Pain scale Middle Aged medicine.disease Surgery Treatment Outcome medicine.anatomical_structure Amputation Female Patient Safety Bone marrow business |
| Zdroj: | Rheumatology. 53:854-859 |
| ISSN: | 1462-0332 1462-0324 |
| Popis: | Objective. SSc causes intractable ischaemic ulcers. To avoid major amputation, we examined the safety and efficacy of therapeutic vascular angiogenesis for digital ulcers due to SSc. Methods. A single-centre, open-label pilot study was conducted in patients with an ischaemic digital ulcer [n = 40, mean age 65 years (S.D. 8), Rutherford class III-5 or III-6) due to lcSSc (n = 11) or arteriosclerosis obliterans (ASO; n = 29). Bone marrow mononuclear cells (0.45.1 10 10 cells in total) were administered into the ischaemic limbs. We evaluated short-term safety and efficacy by means of a pain scale, 99m Tc-tetrofosmin scintigraphy and transcutaneous oxygen tension (TcPO2) before and 4 weeks after treatment. Also, the 2-year outcome was compared. Results. There was a case of amputation in each group within 4 weeks after therapy. The pain scale significantly decreased in both groups [lcSSc 93 mm (S.D .9 ) to 11 ( S.D. 16), P < 0.01; ASO 77 mm (S.D. 22) to 16 (S.D. 13), P < 0.01] and TcPO2 significantly improved [lcSSc 9.0 mmHg (S.D .9 ) to 35 ( S.D. 14), P < 0.01; ASO 18 mmHg (S.D. 10) to 29 (S.D. 21), P < 0.05). At the 2-year follow-up, the limb amputation rate was 9.1% in lcSSc and 20.7% in ASO (P = 0.36), while the recurrence rate was 18.2% in lcSSc and 17.2% in ASO (P = 0.95). All-cause mortality was 27.3% in lcSSc and 17.2% in ASO (P = 0.65). Conclusion. In patients with lcSSc, bone marrow mononuclear cell implantation provides clinical benefit and is safe, without major adverse reactions, and may become an effective strategy. Trial registration: UMIN-CTR, http://www.umin.ac.jp/ctr/index-j.htm, no. UMIN000004112. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|