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CTRI Number  CTRI/2024/10/074805 [Registered on: 07/10/2024] Trial Registered Prospectively
Last Modified On: 06/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Stem Cell Therapy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the Safety and efficacy of Stem Cell Therapy in various Neurological Disorders  
Scientific Title of Study   To Study the Safety and Efficacy of Autologous Bone Marrow Derived Mononuclear Cell Transplant in the Management of Various Neurological Disorders 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anchal Aggarwal 
Designation  Junior Resident 3 
Affiliation  L.L.R. Hospital and G.S.V.M. Medical College 
Address  Department of General Surgery, L.L.R. Hospital and G.S.V.M. Medical College, Kanpur

Kanpur Nagar
UTTAR PRADESH
208002
India 
Phone  7068097939  
Fax    
Email  anchal19940122@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sanjay Kala  
Designation  Professor, Principal and Dean 
Affiliation  L.L.R. Hospital and G.S.V.M. Medical College 
Address  Department of General Surgery, L.L.R. Hospital and G.S.V.M. Medical College, Kanpur

Kanpur Nagar
UTTAR PRADESH
208002
India 
Phone  9839210012  
Fax    
Email  dr_sanjay_kala@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Anchal Aggarwal 
Designation  Junior Resident 3 
Affiliation  L.L.R. Hospital and G.S.V.M. Medical College 
Address  Department of General Surgery, L.L.R. Hospital and G.S.V.M. Medical College, Kanpur

Kanpur Nagar
UTTAR PRADESH
208002
India 
Phone  7068097939  
Fax    
Email  anchal19940122@gmail.com  
 
Source of Monetary or Material Support  
Department of General Surgery, GSVM Medical College and LLR hospital 
 
Primary Sponsor  
Name  Anchal Aggarwal 
Address  Department of General Surgery, L.L.R. Hospital and G.S.V.M. Medical College, Kanpur, UP-208002, India 
Type of Sponsor  Other [Self funded] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anchal Aggarwal  L.L.R. Hospital and G.S.V.M. Medical College  Department of General Surgery, L.L.R. Hospital and G.S.V.M. Medical College, Kanpur
Kanpur Nagar
UTTAR PRADESH 		 7068097939

anchal19940122@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Ethics Committee, GSVM Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G809||Cerebral palsy, unspecified, (2) ICD-10 Condition: G710||Muscular dystrophy, (3) ICD-10 Condition: S349||Injury of unspecified nerves at abdomen, lower back and pelvis level,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Autologous Bone Marrow-Derived Mononuclear Cell Fraction  The posterior iliac crest is often where bone marrow is collected under either local or general anesthesia for the aspiration process. About 80–100 ml of bone marrow is aspirated.A Multidirectional Multiple hole Jamshedi needle by Single puncture site was used to aspirate bone marrow using luer lock syringes with heparin sodium as anticoagulant in a 10 percent solution. The BM aspirate was then filtered through blood transfusion (BT) set filter and injected into Tubex tube (2 tubes used in case of adults and 1 in case of children) then subjected to density gradient separation by two rounds of centrifugation in a centrifugation machine, namely: Br1- 3000rpm for a period of 6 min Br2- 3000rpm for a period of 5 min The MNC concentrate separated after centrifugation is taken for CD34 count and viable cell count. The resulting cells were re-suspended to prepare 10 ml BMMNC to be injected (5 ml in children). The patients were injected either intrathecal or intra-venous or intramuscular depending on the patient’s disease condition. 
Comparator Agent  neurorehabilitation that includes physiotherapy, occupational therapy and speech therapy  patients are offered only neurorehabilitation that includes physiotherapy, occupational therapy and speech therapy 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients with established clinical diagnosis of Cerebral Palsy, Spinal cord injury, Muscular dystrophy or other neurological disorders for whom there were no proven interventions available or if available had been ineffective

 
 
ExclusionCriteria 
Details  Patients with organic brain disorders, Hydrocephalus, CNS Infection, space occupying lesions
Presence of acute infections such as HIV/HBV/ HCV; malignancies, and any other medical conditions such as respiratory infection, cardiac conditions
Patients who are unlikely to adhere to follow-up visits or those who cannot commit to the required follow-up duration
Patients not giving consent for procedure
 
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the safety and to assess the efficacy of autologous bone marrow-derived mononuclear cell therapy in improving neurological function.

 		 0, 3, 6, 9, 12 and 15 months 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the impact of therapy on quality of life in patients with neurological disorders.

 		 0, 3, 6, 9, 12 and 15 months 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   17/10/2024 
Date of Study Completion (India) 01/12/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

 Neurological disorders encompass a wide range of conditions that affect the brain, spinal cord, and nerves throughout the body and includes illnesses like cerebral palsy, spinal cord injuries, and muscular dystrophy, that currently have no known definitive treatments or cures. With their capacity to differentiate into diverse cell lineages, immunomodulatory attributes, and paracrine actions, therapeutic MNCs hold great promise for the treatment of neurological disorders and being autologous have the additional benefit of being safe.

Objectives: To evaluate safety and efficacy of autologous BM-MNCs and their impact on quality of life in patients with neurological disorders.

 200 patients of neurological disorders, will be included in study and each Individual will be injected MNCs intrathecally and/or intramuscularly which will be obtained from the patient’s own blood marrow. 3 such cycles of autologous BM-MNCs will be administered at an interval of 3 months with a mean follow up of 15 ± 1 months from the baseline. 

Autologous MNCs administration, intrathecally as well as intramuscularly can prove to be a safe and efficacious treatment option that produces functional improvements in incurable neurological diseases and hence, a new hope for these patients.

 

 
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