Regenerative MedicineVol. 4, No. 5 News & ViewsFree AccessIndustry Update: Latest developments in stem cell research and regenerative medicineDusko IlicDusko IlicEmbryonic Stem Cell Laboratories, Guy’s Assisted Conception Unit, Division of Reproduction & Endocrinology, King’s College London, UK. Search for more papers by this authorEmail the corresponding author at dusko.ilic@kcl.ac.ukPublished Online:17 Sep 2009https://doi.org/10.2217/rme.09.40AboutSectionsPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInRedditEmail Business Development▪ Collaborations, partnerships & alliancesCodevelopment agreement:The Automation Partnership & University College LondonThe Automation Partnership (TAP) from Cambridge, UK (www.automationpartnership.com) is collaborating with University College London, UK, on the prestigious, Technology Strategy Board funded, Rapid Automated Fabrication of Tissues (RAFT) Project to develop and commercialize novel technology for rapid production of 3D tissues that have the potential to transform drug discovery and regenerative medicine. The 3-year RAFT Project initially aims to manufacture 3D human corneal tissue using corneal limbal stem cells, to determine if this is a viable method of producing a range of different tissue types. Scientists on the RAFT Project at University College London will work on demonstrating preclinical proof-of-concept of the efficacy of these tissues for corneal regeneration. Complex 3D tissues can be produced in less than 1 h by mixing cells with collagen, casting the gel into a mould then compressing it to give a sheet with properties very similar to natural tissue. The 3D structure provides cells with a more natural microenvironment; multiple layers with different cell types can be made with surface features that mimic the stem cell niche and support cell growth and differentiation. Since production of the tissues will be automated, the size, shape, thickness and cell density can all be controlled, and complex features such as capillary-like channels can be engineered into the tissues. This kind of technology should allow high quality and consistent manufacturing of tissues for therapeutic use, such as replacement skin, in cell biology by providing 3D collagen matrices for studying cell behavior or in drug-discovery applications, including toxicity testing by generating skin, cornea and other models.Collaboration agreement:Regenerx & the US Army Medical Research Institute of Chemical DefenseRegenerx Biopharmaceuticals, Inc. (www.regenerx.com) is collaborating with the US Army Medical Research Institute of Chemical Defense (USAMRICD) and Dr Gabriel Sosne, at Wayne State University, MI, USA, to evaluate the ability of thymosin β4 (RGN-259 eye drops) to prevent or reduce damage to the eye caused by exposure to chemical agents. The ability to prevent or reduce such damage is the focus of substantial efforts by both the military and homeland security. The project will consist of a series of research experiments over the next 12 months with thymosin β4, a naturally occurring peptide, a synthetic version of which is being commercially developed by RegeneRx and is in Phase II clinical trials.Licensing agreement:Advanced Cell Technology & CHA Bio & DiostechAdvanced Cell Technology, Inc. from MA, USA (www.advancedcell.com) and a Korea-based stem cell company, CHA Bio & Diostech Co., Ltd. (www.chabio.co.kr) have entered into a licensing agreement under which Advanced Cell Technology will license its proprietary ‘single blastomere technology,’ which has the potential to generate stable cell lines, including retinal pigment epithelium cells for the treatment of diseases of the eye, to CHA Bio for development and commercialization exclusively in Korea. Advanced Cell Technology received an undisclosed up-front license fee.Licensing agreement:Cellular Dynamics International & Mount Sinai School of MedicineCellular Dynamics International from WI, USA (www.cellulardynamics.com) founded by stem cell pioneer James Thomson, has signed an exclusive license agreement with Mount Sinai School of Medicine from New York, USA, to turn stem cells into heart cells. The license will allow Cellular Dynamics to produce cardiac cells and provide them to pharmaceutical and biotech companies that test the toxicity of drugs.Licensing agreement:NeoStem & Regenerative SciencesNeoStem, Inc. from NY, USA (www.neostem.com) has signed an exclusive royalty-bearing license agreement for the Asia territory to use an innovative process that rapidly grows a patient’s own adult stem cells to treat a variety of musculoskeletal diseases. The licensed procedure has been developed by Regenerative Sciences, LLC from CO, USA, focused on developing a medical procedure for the treatment of chronic orthopedic conditions (www.regenexx.com). Known under the name Regenexx™, the innovative outpatient procedure takes stem cells from an individual’s bone marrow, isolates mesenchymal stem cells (which can grow into bone, tendon, muscle, ligament and cartilage), cultures them in a solution containing unique elements from the individual’s own blood and generates millions of stem cells over 2–3 weeks. These cells are then re-injected into the person’s joints or bones in an office procedure to assist in tissue healing and restoration of bone and cartilage.Licensing agreement:Pfizer & the Wisconsin Alumni Research FoundationPfizer, Inc. and the Wisconsin Alumni Research Foundation (WARF; www.warf.org), the private, nonprofit patenting and licensing organization for the University of Wisconsin–Madison, WI, USA, have signed a license for human embryonic stem cell (hESC) patents for the development of new drug therapies. The WARF license provides Pfizer the rights to work with hESCs for drug research and discovery. Securing appropriate licenses in an area as broad and rapidly moving as regenerative medicine helps ensure rapid and efficient utilization of the many existing discoveries and inventions in this field, and allows for the efficient transfer of information for development of future inventions.Licensing agreement:StemSoft & Carter BloodCareStemSoft Software, Inc. from BC, Canada, licensed StemLab, the leading cell therapy and cord blood banking laboratory software, to Carter BloodCare’s Stem Cell Transplant Laboratory in TX, USA (www.carterbloodcare.org). StemLab is designed to manage and streamline the unique workflow followed in the cell therapy laboratory. StemLab assists cell therapy and cord-blood banking laboratories with heightening quality control, managing inventory and generating robust outcome reports including the ability to correlate product manufacture with clinical outcomes.Manufacturing agreement:ImmunoCellular & FormatechImmunoCellular Therapeutics, Ltd. from CA, USA (www.imuc.com) has signed an agreement with Formatech, Inc. from MA, USA (www.formatech.com) for the manufacture of cancer stem cell vaccine product candidate, ICT-121, for an upcoming clinical trial. This agreement calls for Formatech to prepare the vials of the cancer vaccine for the clinical trial under a good manufacturing practices environment. ICT-121 is ImmunoCellular’s cancer stem cell vaccine product candidate consisting of a peptide to stimulate a cytotoxic T-lymphocyte response to CD133, which is generally overexpressed on the cancer stem cells. It is designed as an ‘off-the-shelf’ vaccine. ImmunoCellular will initially evaluate it in a Phase I clinical study for glioblastoma, which the company expects to file an Investigational New Drug application for in the fourth quarter of this year. While glioblastoma will be the initial target for ICT-121, CD133 is also overexpressed in colon cancer, breast cancer, liver cancer, prostate cancer, multiple myeloma and melanoma, providing many potential cancer targets for this cancer stem cell vaccine in the future.Manufacturing agreement:ReNeuron & AngelUK-based ReNeuron Group plc (www.reneuron.com) has signed a contract with Angel Biotechnology Holdings plc (www.angelbio.com), also UK based, under which Angel will manufacture clinical-grade ReN001 stem cell lots for ReNeuron’s Phase I clinical trial with its ReN001 therapy in disabled stroke patients. ReNeuron recently received regulatory approval to commence a Phase I clinical trial in the UK with its lead ReN001 stem cell therapy for disabled stroke patients. The company is developing stem cell therapies for a number of other conditions, including peripheral arterial disease and diseases of the retina. Angel Biotechnology Holdings plc is a biomanufacturing company offering process development services and good manufacturing practices for advanced biologics, supporting biotechnology and pharmaceutical companies worldwide. Angel’s principal activities are the manufacture and supply of materials for use in early-stage drug development and preclinical studies, along with drug product and Chemistry, Manufacturing and Controls documentation for Phases I, II and III clinical trials and the manufacture of licensed drugs or vaccines. Angel specializes in the provision of advanced biologics; these include autologous and allogeneic cell therapy products, stem cells, cellular vaccines, specific purified natural and recombinant proteins, and bacteriophage.Marketing agreement:Harvest Technologies & LifeCellHarvest Technologies from MA, USA (www.harvesttech.com) announced a sale and marketing relationship with LifeCell International, India’s stem cell banking service provider, and a pioneer in stem cell research and technology in India. Together these companies will bring Harvest’s Bone Marrow Aspirate Concentrate technology system to the Indian market. Existing methods to produce a stem cell concentrate therapy are time consuming, labor intensive and require complex logistical considerations. The Bone Marrow Aspirate Concentrate System helps in safe and rapid preparation of cell concentrate from bone marrow. The process only takes approximately 15 min and can be conducted at the point-of-care setting.Partnership agreement:GE & CytoriGE Healthcare (www.gehealthcare.com), a unit of General Electric Company, and Cytori Therapeutics from CA, USA (www.cytoritx.com) announced an agreement by which GE Healthcare will commercialize Cytori’s StemSource® technology in the North American stem cell banking and research markets. The StemSource technology includes automated equipment to process stem and regenerative cells found in adipose tissue, cryopreserve them or use them directly for research purposes. In January 2009, Cytori and GE Healthcare formed a separate agreement to commercialize Cytori’s products in ten European countries. This includes selling the Celution® 800/CRS System in the European cosmetic and reconstructive surgery market as well as selling StemSource products in the European cell banking and research markets.Partnership agreement:GE & GeronGE Healthcare and Geron from CA, USA (www.geron.com) have entered into a global exclusive license and alliance agreement to develop and commercialize cellular assay products derived from hESCs for use in drug discovery, development and toxicity screening. Financial terms are not being disclosed. Under the terms of the agreement, GE Healthcare has been granted an exclusive license under Geron’s extensive IP portfolio covering the growth and differentiation of hESCs, as well as a sublicense under Geron’s rights to the foundational hESC patents held by the WARF (www.warf.org). The program will use stem cells derived from hESC lines listed on the NIH Human Pluripotent Stem Cell Registry. GE Healthcare will fund the R&D program and will be responsible for manufacturing, sales and distribution of products developed under the agreement. After the biotech company announced that it is teaming up with GE Healthcare to develop ESC products the share price of Geron shot up 23%.Sponsored research agreement:Neuralstem & China Medical University of TaiwanNeuralstem, Inc. from MD, USA (www.neuralstem.com) has entered into a sponsored research agreement with the China Medical University & Hospital of Taiwan (Taichung, Taiwan) to prepare for a human clinical trial using Neuralstem’s human spinal cord neural stem cells to treat stroke patients. The therapy will focus on patients whose poststroke symptoms, including complete or partial paralysis, have stopped improving more than 6 months after an ischemic stroke.▪ Launching new products & servicesInvitrogenInvitrogen, a division of Life Technologies based in the USA (www.invitrogen.com), launched a new technology to enable the development of safer stem cell therapies. Dynabeads® SSEA-4 addresses a key challenge in translational research by separating undifferentiated stem cells from those that are differentiated. Scientists from Invitrogen and the Buck Institute for Age Research, located in CA, USA, collaborated in developing this innovative solution that depletes greater than 99% of undifferentiated hESCs from differentiated populations. Dynabeads SSEA-4 achieves this by utilizing magnetic beads that latch onto SSEA-4, a common marker on embryonic and induced pluripotent stem cells (iPSCs), removing them from a mixed population culture in less than 45 min leaving behind differentiated cells unaffected by the process.Rubicon GenomicsRubicon Genomics, Inc. from MI, USA (www.rubicongenomics.com), a developer of pre-amplification products that enable optimal performance of the most advanced genetic analysis tools, announced the release of its PicoPlex™ Single Cell Whole Genome Amplification (WGA) kit – a more rapid, accurate and reproducible method for amplifying single genomes than current technologies. This product targets the pre-implantation genetic diagnostics, cancer research and stem cell research markets, which require rapid, reproducible amplification to profile patient genotypes, karyotypes and mutations. PicoPlex enables reference labs to begin qPCR, microarray or sequencing analysis less than 3 h after collecting patient cells. Current single-cell WGA kits using molecular displacement amplification technology do not offer reproducible amplification of whole genomes, causing sporadic allele and locus dropouts, which seriously compromise results in pre-implantation genetic diagnostics. Hence, microarray and qPCR genetic analysis of single cells using molecular displacement amplification-amplified DNA is noisy and produces unreliable data. PicoPlex Single Cell WGA kits reliably extract more genetic information from single cells with minimal background. Specifically, the kit reproducibly amplifies total DNA 1 million-fold from single cells to produce 5 µg of amplified DNA in less than 3 h.Snoasis MedicalSnoasis Medical from CO, USA (www.snoasismedical.com) is initiating commercial distribution of BioCover™. BioCover is the first membrane composed of donated amnion tissue for use as a wound covering in the treatment of gingival recession (receding gums). BioCover is a dehydrated graft, which does not need to be hydrated prior to use; it naturally adheres to the surgical site. This sets it apart from current methods – eliminating the need for hydration and the need for sutures to hold the graft in place, thus resulting in a quicker and easier procedure. In addition, the lack of intrusion and trauma to the gums decreases the patient’s postsurgery pain and recovery time. Amnion is the innermost lining of the placenta, which encloses the unborn baby through term. Amnion tissue, donated from mothers who undergo elective cesarean section surgery, has been used for over a decade by ophthalmologists. It is procured and processed according to standards established by the US FDA and The American Association of Tissue Banks. An additional assurance of safety is achieved by terminally sterilizing each graft. Since its first recorded use on burn victims in 1910, amnion tissue has never elicited an adverse reaction.▪ AdvancementsAdvanced Cell TechnologyAdvanced Cell Technology, Inc. from MA, USA (www.advancedcell.com) and its collaborators at the Casey Eye Institute at Oregon Health and Science University, USA (www.ohsucasey.com) reported the long-term safety and efficacy of hESC-derived retinal pigment epithelium produced under manufacturing conditions suitable for human clinical trials [1]. Two important early potential hESC applications are the use of retinal pigment epithelium for the treatment of age-related macular degeneration and Stargardt disease, an untreatable form of eye disease that leads to early-onset blindness. The research demonstrates long-term functional rescue using hESC-derived cells in both the Royal College of Surgeons (RCS) rat and Elov14 mouse, animal models of retinal degeneration and Stargardt, respectively. The cells survived transplantation for prolonged periods (>220 days) and sustained visual function without tumor formation or untoward pathological reactions. Near-normal functional rescue was also achieved in the Stargardt mouse. To further address safety concerns, a study was carried out in the NIH III immune-deficient mouse model. Long-term data (spanning the life of the animals) revealed no evidence of tumor formation after transplantation.DaVinci BiosciencesDaVinci Biosciences LLC from CA, USA (www.dvbiosciences.com) in collaboration with University of Utah (UT, USA), Southern California Center for Regenerative Medicine (CA, USA) and Omni Hospital in Ecuador announced the discovery of a previously unidentified stem cell population from adult human testis [2]. Termed gonadal stem cells (GSCs), these adult-derived stem cells, unlike previous reported population of stem cells found within the testis, have been found to demonstrate adult stem cell properties. GSCs express CD105, CD166, CD73, CD90 and STRO-1 and lack hematopoietic markers CD34, CD45 and HLA-DR, which are characteristic identifiers of mesenchymal stem cells. In addition, GSCs express pluripotent markers Oct4, Nanog and SSEA-4. GSCs propagated for at least 64 population doublings and exhibited clonogenic capability. GSCs have a broad plasticity and the potential to differentiate into adipogenic, osteogenic and chondrogenic cells. The study evolved from an international collaboration aimed at identifying novel cell populations at different geographical laboratory locations and for different HLA types.International Stem Cell CorporationInternational Stem Cell Corporation (ISCO) from CA, USA (www.internationalstemcell.com) has received positive early results from animal trials designed to improve photorefractive keratectomy, a form of corrective laser eye surgery that offers an improved alternative to laser-assisted in situ keratomileusis (LASIK). Photorefractive keratectomy is generally thought to be safer and to produce better long-term results than LASIK, but has not been used as frequently because of patient discomfort following surgery and a longer healing time. The first-stage animal trials just completed demonstrated that ISCO’s corneal cells manufactured by ISCO’s subsidiary, Lifeline Cell Technology, encouraged corneal defect healing in the animals. The trials are the first step toward gaining FDA approval to test the efficacy of using ISCO’s cells to improve healing after corneal surgery, and could result in the first FDA-approved use of human cells produced by ISCO.▪ ExpansionLonzaSwiss-based Lonza Group, Ltd (www.lonza.com) is expanding its Cell Therapy business with the construction of a new facility in Singapore. This new facility will broaden the global presence of Lonza in the area of Cell Therapy production. The new facility will be located adjacent to Lonza’s large-scale mammalian manufacturing facility at Tuas Biomedical Park. The total investment for the first phase will be approximately US$28 million (CHF 30 million).Clinical Trials▪ AastromOn 22 May 2009, Aastrom Biosciences, Inc. from MI, USA (www.aastrom.com) has temporarily suspended enrollment and patient treatment in its US Phase II IMPACT-DCM clinical trial following a report that a patient died at home after being released from the hospital following treatment in the trial. The patient’s cause of death is the subject of an investigation at the clinical site. Furthermore, an independent Data Safety Monitoring Board is assessing the circumstances of the event. In accordance with standard operating procedures, the company has informed the FDA of the following: the death of the patient after being released from the hospital; the initiation of an investigation into the cause of death; and that the company has voluntarily suspended patient enrollment and treatment in the trial. Subsequently, the FDA placed the trial on temporary clinical hold pending an investigation. Follow-up of patients previously enrolled in the IMPACT-DCM trial is being continued in accordance with study protocol. Aastrom Biosciences shares slid 24% on the news. On 17 June 2009, the FDA informed Aastrom that it had completed its investigation into the death of a patient following treatment with the company’s cardiac repair cells and that the clinical hold had been lifted; therefore, the IMPACT-DCM clinical trial could resume. Based on autopsy results and medical records, the FDA, the clinical site’s principal investigator and an independent Data Safety Monitoring Board have attributed the patient death to progression of the disease and determined it was unrelated to the cardiac repair cells treatment. As soon as the FDA has removed the clinical hold from the clinical trial, the patient enrollment resumed at all five initiated clinical sites.▪ Cardio3 & BiotronikBiotronik, a German pioneer in wireless remote monitoring technology for patients with cardiac devices, entered in a partnership agreement with Belgian biotechnology company Cardio3 BioSciences in their C-Cure® stem cell clinical trial. This pivotal trial is designed to evaluate the safety and efficacy of Cardio3 BioSciences’ second-generation stem cell therapy in patients with heart failure. The first patient was treated in March 2009. As part of a commitment to providing optimal therapy, patients who participate in the trial will receive an implantable cardioverter defibrillator with Home Monitoring®. These devices ensure optimal standard of care for patients with severe cardiac conditions. Biotronik Home Monitoring offers the most advanced remote monitoring for cardiac patients employing cellular technology in the third generation. The Biotronik Home Monitoring system safely reduces the need for conventional in-office visits, while improving follow-up adherence, and enables earlier evaluation of clinically relevant cardiovascular events.▪ CytoriCytori from CA, USA (www.cytoritx.com) completed enrollment in the study to investigate adipose-derived stem and regenerative cells in chronic heart disease. The trial, which has been named the PRECISE study, is being carried out at leading cardiology centers in Europe. It specifically enrolled patients suffering from an advanced form of chronic myocardial ischemia, for which there is no generally accepted treatment. The trial enrolled 27 patients and was designed as a double-blind, randomized, placebo-controlled, dose-escalation study. The patients’ own cells were extracted from adipose tissue and processed for delivery at the point of care using Cytori’s Celution® System. The cells were then injected back into the patients using the NOGA® XP System (Biologics Delivery Systems, Cordis Corp., a Johnson and Johnson company), which identifies and guides cells to damaged regions of the heart. The primary objectives of the study were to assess the safety and feasibility of Cytori’s Celution System as part of a novel procedure for chronic heart disease. The company believes it will be able to fully assess these primary objectives with the data obtained from 27 patients (the protocol allowed for up to 36 patients). Furthermore, the independent Data Safety and Monitoring Board had not identified any safety concerns relating to the Celution output or the procedure; 6-month results are expected in the first half of 2010.▪ Fate TherapeuticsFate Therapeutics, Inc. from CA, USA (www.fatetherapeutics.com) announced that the first patient has been treated in a Phase Ib clinical trial of FT1050, a small molecule stem cell modulator designed to increase hematopoietic stem cell (HSC) number and function through its activation of key pathways that guide cell fate. The study, which is being conducted at the Dana-Farber Cancer Institute in Boston, MA, USA, will determine the safety and tolerability of introducing FT1050 during the standard course of dual umbilical cord blood transplant in adult patients with hematologic malignancies, such as leukemia and lymphoma, who have undergone nonmyeloablative conditioning therapy. Fate Therapeutics is developing FT1050 to improve the overall efficiency of HSC treatment by enhancing HSC proliferation and homing to the bone marrow.▪ Gamida Cell & TevaFive cord-blood transplantation centers in Spain (three in Barcelona and two in Valencia) have joined the ExCell study for the safety and efficacy of StemEx® as a treatment for hematological malignancies, including leukemia and lymphoma, in a single-arm, global, pivotal marketing authorization trial. StemEx is a graft of expanded stem/progenitor cells derived from a single unit of umbilical cord blood and transplanted in combination with nonexpanded cells from the same unit. StemEx is being developed by a joint venture of Gamida Cell and Teva Pharmaceutical Industries, both from Israel.▪ MesoblastAustralia’s regenerative medicine company, Mesoblast, Ltd (www.mesoblast.com), announced positive 3-month interim efficacy results from the first 20 patients enrolled in the Phase II heart failure trial of the proprietary allogeneic, or ‘off-the-shelf’, adult stem cell product Revascor™. Patients with moderate-to-severe congestive heart failure demonstrated significantly improved heart muscle function 3 months after receiving a single injection into damaged heart muscle of the lowest dose of Revascor. The randomized, placebo-controlled Phase II trial is being run at multiple centers in the USA by Mesoblast’s US-based associated company, Angioblast Systems, Inc from NY, USA (www.angioblast.com). The trial aims to compare one of three increasing doses of Revascor against standard of care in up to 60 patients suffering from moderate-to-severe congestive heart failure, defined as a baseline ejection fraction (EF) of 40% or lower by echocardiogram. On the basis of the positive interim efficacy results and the excellent safety profile seen to date in the first group of patients receiving the lowest dose of Revascor, the second group of patients set to receive the next higher dose is currently in active recruitment. In the first 20-patient cohort, 15 were randomized to receive the lowest dose of Revascor and five were randomized to the control arm. While control patients with a baseline EF of 40% or below demonstrated an 11% mean decrease in EF over the first 3 months (mean EF values decreased from 31 to 27), patients with a baseline EF of 40% or below who received a single injection into the damaged heart muscle of the lowest dose of Revascor showed a 37% mean increase in EF over this period (mean EF increased from 28 to 37, p = 0.017). The 10-point mean difference in absolute EF at 3 months between cell-treated and control patients was significant (p < 0.05). Patients with the most severe and advanced heart failure, defined as a baseline EF below 30% (nine patients treated with Revascor), had an even greater improvement in heart function, with a mean increase in EF over 3 months of 50% (p = 0.02).In the second press release, Mesoblast announced successful results from the first five patients who underwent bone marrow transplantation with hematopoietic stem and progenitor cells expanded by the patented allogeneic, or ‘off-the-shelf’, mesenchymal precursor cells (MPCs). The Phase I/II trial in up to 30 patients is being conducted by Mesoblast’s US-based associated company Angioblast Systems, Inc. at the University of Texas MD Anderson Cancer Center, Department of Stem Cell Transplantation and Cellular Therapy, TX, USA. The trial is funded through a grant awarded by the US NIH. Successful bone marrow reconstitution and engraftment was achieved in all five patients with hematologic malignancies who received MPC-expanded hematopoietic stem and progenitor cells from cord blood, with no cell-related adverse events. The median time to engraftment was 15 days, approximately 2 weeks faster than expected without MPC expansion. The MPC product used in this trial is being developed under a FDA Orphan Drug Designation recently granted to Angioblast Systems, Inc. for expanding hematopoietic stem and progenitor cell numbers in patients with hematologic malignancies.▪ OsirisOsiris Therapeutics, Inc. from MD, USA (www.osiris.com) announced 6-month interim data from a Phase II clinical trial evaluating Prochymal™, the company’s proprietary formulation of adult mesenchymal stem cells, for the treatment of chronic obstructive pulmonary disease (COPD). A total of 62 patients (58% male) were enrolled and are being followed for 2 years in the placebo-controlled study. The patients ranged in age from 47 to 80 years and suffered from moderate (n = 23) to severe (n = 39) COPD. Patients had been suffering with COPD for an average of 7.8 years. Patients with asthma were excluded from the trial. At the 6-month time point, the data revealed several important findings: ▪ The trial met its primary goal of demonstrating the safety of Prochymal in patients with compromised pulmonary function at the 6-month evaluation point. All patients in the trial completed the planned course of four infusions without any evidence of infusional toxicity. Oxygen saturation levels were measur