Cytori Therapeutics, Inc. Completes Patient Enrollment in SCLERADEC II
January 22, 2018 at 09:00 am
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Cytori Therapeutics, Inc. announced completion of patient enrollment in SCLERADEC II (NCT02558543), a randomized, double-blind, placebo-controlled, parallel group, multi-center clinical trial intended to study the safety and efficacy of Habeo™ Cell Therapy in up to 40 subjects with impaired hand function due to scleroderma (systemic sclerosis). In this investigator-initiated clinical trial supported by Cytori, a total of 40 patients were enrolled among 5 French centers: Marseille, Montpelier, Rouen, Lyon, and Paris. The primary endpoint is improvement over baseline in the Cochin Hand Function Scale at 3 months. Full analysis of the unblinded data set, including results for secondary endpoints such as pain, quality of life, mobility, strength, tactile sensitivity, Raynaud’s Phenomenon, and vascular suppression, will be performed upon completion of the final patient’s 6 month follow-up visit. Data will be available in the second half of 2018 and may support potential future regulatory submissions in Europe and selected regions. In SCLERADEC II, all patients had Habeo Cell Therapy prepared from their adipose tissue. Patients randomized to the treatment arm had cells administered to their fingers via injections on the same day while patients randomized to receive placebo, had their cells cryopreserved for future use. The open-label crossover arm in the trial allows patients randomized to placebo to receive their cryopreserved cells after 6 month data have been analyzed and reviewed by an independent monitoring committee. Eligible patients electing to receive treatment with cryopreserved cells will be followed for both safety and efficacy for 6 months.
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company. The Company is developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers. The Company combines image-guided local beta radiation and targeted drug delivery approaches. The Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). Its radiotherapeutic candidate, rhenium (186Re) obisbemeda, is designed specifically for CNS cancers including GBM, LM, and pediatric brain cancers (PBC). The Companyâs Rhenium (186Re) obisbemeda, a novel injectable radiotherapy designed to deliver targeted, high dose radiation directly into GBM tumors. Its radiotherapeutic candidate, Rhenium-188 NanoLiposome Biodegradable Alginate Microsphere (188RNL-BAM), is designed to treat many solid organ cancers.