Regulatory : Medical Plastics Data Service

Application for Manufacturing of Experimental test batches for test and Analysis (Form 30) to the SLA

Joint inspection by Expert/SLA/ CDSCO Official?Permission for Manufacturing of Experimental batches of SCCPs for Test and Analysis (Form-29) ?Pre -clinical studies as per Schedule Y? Application and protocol submission for conducting Phase I/II/III clinical study with the Experimental batches (Form 44) ? (Pre -clinical data, Protocol for Clinical trial, CMC data as well as General Information as per CDSCO Guidance for Industry? CBBTDEC-Review of Application in consultation with subject Experts?Submission of Clinical Study Report of Phase I/II/III of SCCPs?Consultation with Subject Experts of (CBBDTEC)?

Market Authorization Application in line with CTD format from manufacturer Along with phase clinical trial report

(Module-1: Administrative information) (Module-2: Overall Quality Summary)
(Module-3: Chemistry Manufacture, Control (CMC))
(Module-4: Non – clinical data)
(Module-5: Clinical Data)

Application to Import of finished formulation of SCCPs for Test and Analysis in small quality (Form 12) ? Application and protocol for conducting Phase III clinical study(Form 44) ?(Pre - clinical data, Protocol for Clinical trial, CMC data as well as General Information as per CDSCO Guidance for Industry) ? CBBTDEC-Review of Application in consultation with Subject Experts? Application and protocol for conducting Phase III clinical study (Form 44) ?(Pre - clinical data, Protocol for Clinical trial, CMC data as well as General Information as per CDSCO Guidance for Industry) CBBTDEC-Review of Application in consultation with Subject Experts.

SN	CDSCO Approval Date	Stem cells Product Name	Indication/Therapeutic applications
1	15-Mar-17	Autologous Adult Live Cultured Chondrocytes in DMEM suspension for implantation (CHONDRON)	Articular Cartilage Defects (Autologus Nature)
2	15-Mar-17	Adult Human Bone Marrow derived, cultured, pooled Allogeneic Mesenchymal Stromal Cells (Stempeucell® )	CLI due to Buerger's Disease
3	17-Mar-17	Autologous Adult Live Cultured osteoblasts in DMEM suspension for implantation (OSSRON)	Avascular Necrosis of Hip Joint
4	17-Mar-17	Dendritic cell immunotherapy product (APCEDEN ®)	Malignant Solid Tumours (Prostate, Ovarian, Colorectal and Lung Cancer)
5	28-Mar-17	Irradiated allogenic cancellous Bone & Marrow (CANPAR)	Scaffolding for correcting, reconstructing, filling, repairing or rebuilding bone in dental defects
6	28-Mar-17	Irradiated allogenic Cortical Bone & Marrow (CORPAR)	Scaffolding for correcting, reconstructing, filling, repairing or rebuilding bone in dental defects
7	28-Mar-17	Irradiated allogeneic Bone Block & Marrow (BB)	Scaffolding for correcting, reconstructing, filling, repairing or rebuilding bone in dental defects
8	27-Dec-17	Decellularized Dermis	Indicated for Homologous use for the replacement of damaged skin due to Diabetic foot ulcer, Venous leg ulcer, Dehisced surgical wounds and Traumatic burns.
9	04-Mar-20	Autologous Adult live cultured Buccal Epithelial Cells Uregrow	For the treatment of bulbar urethral stricture of at least 1-2 cm in length in males for age group IB-56 years.
10	07-Aug-20	Stempeucel (Adult human Bone Marrow Derived, Cultured Pooled, allogenic Mesenchymal Stromal cells	Clinical Limb Ischemia due to Atherosclerotic Peripheral arterial disease in Rutherford 111-5 or 111-6, not eligible for or have failed traditional revascularization treatment, with rest pain and / or ulcers in the affected limb.

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