About StemCreDB

The StemCreDB is designed to help both developers to establish a developmental strategy and regulatory authorities to set up a regulatory policy in advance by providing extensive information on clinical development trend initiated by industry.

This site offers two different databases, one comprised of published stem cell-based clinical trial articles and the other comprised of registered stem cell based clinical study protocols.




About Published Clinical Papers DB

Single search in Pubmed with the search term of stem cell gives around 2 million results as of early 2016. It is extremely hard to find clinical trial articles out of those 2 million papers, and it’s even more challenging to find a specific information associated with stem cell-based clinical trial articles.

The StemCreDB is a database of only stem cell-based clinical articles constructed by the systematic search in the Pubmed. The database, also, collected the clinical articles using the bone marrow mononuclear cells as a stem cell-based treatment to help researchers in this area.

Milestone

Stem cell research milestone is consisted of published clinical articles.
You can look at a glance of stem cell clinical research milestones by disease categories:

  • Cardiovascular disease: AMI, CMI, Dilated cardiomyopathy
  • Bone disease: bone defect, Nonunion, OA, ON of femoral head, Spine DISC, Psudoarthrosis of Tibia, Mandible lesion, Osteochondritis, Cartilage defect, Spine disease, bone defect in skull, Systemic disease
  • Neurology disease: Stroke, TBI, SCI, CP, MS, ALS, PD, HD
  • Autoimmune disease: aGVHD, Crohn’s Disease, SLE, SS
  • Gastrointestinal disease: Crohn's disease, T1DM, T2DM, Liver Cirrhosis, Celiac disease, Pancreatitis, hepatitis, Intestinal bowel disease
  • Pulmonary disease: ARDS, BPD, COPD, Pulmonary Hypertension, Sepsis, IPF
  • Urinary disease: Erectile dysfunction, Peyronie’s disease, Stress urinary incontinence, Bladder underactivity, Bladder outlet obstruction, Lower Urinary tract reconstruction, Kidney disease

Stem cell research milestone, including Gastrointestinal disease, Pulmonary disease, and Urinary disease will be uploaded soon.
Eye disease, ENT disease, and Skin disease stem cell research milestone will be uploaded in 2017.

Article Search

You can search easily specific articles using various search terms among over 1,000 stem cell-based clinical articles uploaded in the StemCreDB. Data search is available for:

  • Study object: Clinical safety, Clinical efficacy, Pharmacokinetics, Pharmacodynamics, Dose finding, Biovigliance
  • Phase: pilot study, Phase 1, Phase1/2, Phase 2, Phase 3, Phase 4
  • Study design: single group assignment, single group with historical control, non random trial, RCT, cross over, others (CRCT, Factorial design et al)
  • Stem cell type: HPSC, MNC: BM, MNC: PB, SVF, MSC: BM, MSC: AD, MSC: UC, MSC: Others, Organ stem cell, MSC_differentiation, iPS_differentiation, ESC_differenctiation, Other cells, Other tissues
  • Route of delivery : Parenchyma, Intrathecal, IA, IV, IC, IM et al
  • Follow-up points: Under 3months, 4-6months, 7-12months, 13-24months, 36months, 48months, over 60 months, individual follow-up
  • Measurement Tool: MRI, Ultrasonography, SPECT, Angiography, ECG, PET_CT, CT, x-ray et al.

Currently in 2016, the published research articles on cardiovascular, bone, neurology, autoimmune, gastrointestinal diseases, pulmonary disease, and urinary disease are being collected and those on other disease areas are expected to be uploaded soon. Literature reviews on new research articles are being quarterly updated.

Interactive Charts

Interactive visual Analysis is to discover information in data which is not readily apparent in simple graphing.

1) Interactive Charts for published stem cell clinical research articles

This tool will visualize detail analysis results obtained from multiple disease groups at one view as well as a single disease group. If you select a certain data bar of your interested, sub-group analysis result for the selected group will automatically appear.
You can identify stem cell-based clinical research trends in both efficacy and safety evaluation through effective visual information.

  • Detailed analysis by disease in efficacy assessmen
  • Detailed analysis by disease in safety assessment
  • Stratified analyses by disease, study design, stem cell type

Through this database, we hope to help stem-cell researchers have easily access to the stem cell-based published researches related to pharmacodynamics, pharmacokinetics, dose finding studies, clinical efficacy, clinical safety, and biovigilance, which are essential to develop state-of-the-art stem-cell based materials.

2) Interactive Charts for registered stem cell clinical protocols





Registered Clinical Trials DB : Data Source

Currently, the database is sourced from one of the clinical trial registries, www.clinicaltrials.gov. Since the registration of clinical protocol is compulsory only for those conducted in the USA, there can be a gap between those found in this registry and actual state in outside of USA. Therefore, any data originated from this DB should be considered as one of the reference parameters to read the current trend of industry-initiated clinical development not as a definitive one. Also, this site is intended to provide information on Industry-sponsored clinical protocols registered in www.clinicaltrials.gov, meeting a set of predefined inclusion/exclusion criteria as mentioned below. Upon any usage of this DB, the scope of data should be carefully considered as well. For the purpose to provide annual statistics, this DB is annually updated as of the last day of the previous year, and the update is usually applied to this website every Februaries.

Registered Clinical Trials DB : Data Selection Method

The primary search was performed with a search term of ‘stem cell’ at the website, www.clinicaltrials.gov.
The first screening was achieved by limiting the search result to those sponsored or collaborated by industry, which could be done by selecting ‘Industry’ in the ‘By Category’ of the ‘Sponsor Collaborators’ sub-menu under ‘By Topic’ menu.
All retrieved search result was manually screened to select those meet the following inclusion/exclusion criteria.

Inclusion Criteria
  • Those sponsored by or collaborated with the industry sectors
  • Those to study interventional therapy
  • The study treatment should be involved with a therapeutic product requiring pre-market approval by local authorities. Since discrepancies may exist among local regulations, only those subject to Section 351 of the Public Health Service (PHS) per US regulatory system were included in this DB.
  • For the nature of the source DB (www.clinicaltrials.gov), any information on the studies outside of USA solely rely on the claims made by the registrant. Therefore we are not responsible for verifying the authenticity of the information for those studies.
  • Regardless of jurisdictional definition, any medical product associated with stem cell for its primary function or critically involved in processing stem cell-based therapeutics (e.g. cell sorters, cell trainers, etc.)

Exclusion Criteria
  • Non-interventional study including observational study and follow-up study
  • Investigator-initiated study
  • Those stopped with no patient enrollment
  • Those withdrawn voluntarily or found unknown or suspended/stopped by the regulatory authority for any reasons

All data is subject to change depending on the update of source information and/or revision of inclusion/exclusion criteria for research purpose of this DB. Therefore, the users are strongly advised referring to the last update date and the latest inclusion/exclusion criteria.

Registered Clinical Trials DB : Notes

■ Country
It’s frequently found that the country where the study is conducted is different from the one where the company is located in or that more than one country or sponsor are involved in a single study. For the purpose of this DB to provide industrial development status, the country in any analysis provided in this website indicates where the current primary sponsoring company is located.

■ Year
The year in any analysis provided in this website was determined based on the (planned) starting year of the study.

■ Indication
The anatomical organ or system affected by the disease is not always the same to those of therapeutic target. When there are more than one organ or system are involved, therapeutic target was chosen for the classification of indication over the anatomical localization of the lesion. For example, degenerative arthritis was classified as an orthopedic disease while rheumatoid arthritis was classified as an immune disorder. In current DB, indication was classified into one of the following categories:

  • Heart Heart disease
  • Vascular Vascular disease
  • Skin Skin disease
  • GI Gastrointestinal disease
  • Blood Hematologic disease
  • Immune Immune disease
  • Orthopedic Musculoskeletal disease
  • Neuronal Neuronal disease
  • Cancer Malignant disease
  • Eye Eye disease
  • Other Other
  • Urologic Urologic disease
  • Reproductive Reproductive system disease
  • Lung Lung disease
  • Genetic Genetic disease

■ Phase
Though there is a theoretical definition to differentiate the study phase, no definitive rules to define the phase of a study exists in a real-world setting. Therefore, the phase in this DB mirrors as claimed on the source registry by the registrant, which includes Phase I, I/II, II, II/III, and III.

■ Cell Origin
Depending on the cell origin, study treatments are classified into autologous (collected from an identical individual), allogeneic (collected from a different donor), or xenogenic (collected from an organism of a different species).

■ Cell Type
Though there is still a controversy over the definition of type of stem cells, cell type was classified as follows considering the claims by the study registrant found in the source registry and generally acceptable terms:

  • HSC Hematopoietic stem cell
  • MSC Mesenchymal stromal/stem cell
  • NSC Neural stem cell
  • ESC-derived Embryonic stem cell derived
  • Others Others

■ Cell Source
The source where the stem cell was collected was classified into following categories:

  • BM Bone marrow
  • CB Cord blood
  • Adipose Adipose tissue
  • PB Peripheral blood
  • ESC Embryonic stem cells
  • Others Others

■ Manipulation Type
Study treatments are frequently associated with a range of ex vivo manipulation of the stem cells in addition to the most commonly used process, selection and in vitro expansion. In this DB, manipulation type indicates the additional manipulation type to the common process of selection and in vitro expansion that is referred to as selection and ex vivo expansion, as follows:
  • expansion selection, ex vivo expansion, selection
  • differentiation differentiation, pre-conditioning
  • gene-modified gene modification
  • multi-population multiple cell population
  • tissue-engineered tissue-engineering
  • combination combined with device
  • device companion device

The StemCreDB is operated by the Center for Evaluating Next-Generation Stem Cell-based Therapeutics (CENST) and funded by the Ministry of Food & Drug Safety (MFDS) in Korea.

Copyright 2016 CENST all rights reserved.